History of Changes for Study: NCT02407236

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)

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Study Record Versions

Version	Submitted Date	Changes
1	March 30, 2015	None (earliest Version on record)
2	April 20, 2015	Study Status
3	May 11, 2015	Study Status
4	June 1, 2015	Study Status
5	July 14, 2015	Study Status
6	August 11, 2015	Study Status and Contacts/Locations
7	September 23, 2015	Contacts/Locations and Study Status
8	October 16, 2015	Recruitment Status, Contacts/Locations and Study Status
9	November 6, 2015	Contacts/Locations and Study Status
10	November 27, 2015	Contacts/Locations and Study Status
11	December 21, 2015	Contacts/Locations and Study Status
12	January 12, 2016	Contacts/Locations and Study Status
13	February 2, 2016	Contacts/Locations and Study Status
14	February 23, 2016	Contacts/Locations and Study Status
15	March 15, 2016	Contacts/Locations and Study Status
16	April 5, 2016	Contacts/Locations and Study Status
17	April 22, 2016	Contacts/Locations and Study Status
18	May 13, 2016	Contacts/Locations and Study Status
19	June 1, 2016	Contacts/Locations and Study Status
20	June 22, 2016	Contacts/Locations and Study Status
21	July 13, 2016	Contacts/Locations and Study Status
22	August 3, 2016	Contacts/Locations and Study Status
23	August 24, 2016	Contacts/Locations and Study Status
24	October 14, 2016	Contacts/Locations and Study Status
25	November 12, 2016	Contacts/Locations, Study Status and Oversight
26	December 12, 2016	Contacts/Locations and Study Status
27	February 10, 2017	Contacts/Locations and Study Status
28	March 10, 2017	Study Status and Contacts/Locations
29	March 21, 2017	Contacts/Locations and Study Status
30	April 20, 2017	Contacts/Locations, Study Status and Oversight
31	May 16, 2017	Study Status and Contacts/Locations
32	June 13, 2017	Contacts/Locations and Study Status
33	July 11, 2017	Study Status and Contacts/Locations
34	August 8, 2017	Contacts/Locations and Study Status
35	September 6, 2017	Recruitment Status, Contacts/Locations, Study Status and Study Design
36	November 28, 2017	Study Status and Contacts/Locations
37	February 26, 2018	Study Status and Contacts/Locations
38	March 21, 2018	Study Status and Study Design
39	August 13, 2018	Study Status and Study Design
40	October 3, 2018	Study Status
41	October 31, 2018	Study Design and Study Status
42	November 28, 2018	Study Status and Study Design
43	March 21, 2019	Study Status and Study Design
44	April 18, 2019	Study Status and Contacts/Locations
45	May 16, 2019	Study Status and Study Design
46	June 13, 2019	Study Status
47	August 8, 2019	Study Status
48	August 26, 2019	Arms and Interventions and Study Status
49	October 31, 2019	Study Status
	Results Submission Events
November 15, 2019		Returned after QC review: December 4, 2019
50	December 20, 2019	Outcome Measures, Study Status, More Information, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and Study Design
51	January 21, 2020	Study Status
52	February 18, 2020	Study Status and Contacts/Locations
53	March 17, 2020	Study Status
54	April 14, 2020	Study Status and Contacts/Locations
55	May 12, 2020	Study Status
56	July 7, 2020	Study Status
57	September 29, 2020	Study Status and Contacts/Locations
58	October 27, 2020	Study Status
59	November 24, 2020	Study Status
60	December 22, 2020	Contacts/Locations and Study Status
61	January 19, 2021	Study Status
62	March 16, 2021	Study Status
63	April 12, 2021	Study Status
64	May 11, 2021	Study Status
65	June 7, 2021	Study Status
66	July 6, 2021	Study Status
67	August 3, 2021	Contacts/Locations and Study Status
68	August 31, 2021	Study Status
69	September 28, 2021	Study Status
70	October 26, 2021	Study Status
71	November 23, 2021	Study Status
72	February 2, 2022	Recruitment Status and Study Status
73	August 2, 2022	Study Status and Contacts/Locations
74	November 29, 2022	Adverse Events, Participant Flow, Baseline Characteristics, Study Status, Document Section and More Information
75	January 3, 2023	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CR106920
Brief Title:	A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)
Official Title:	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary IDs:	2014-005606-38 [EudraCT Number] CNTO1275UCO3001 [Janssen Research & Development, LLC]

Study Status


Record Verification:	April 2017
Overall Status:	Recruiting
Study Start:	July 10, 2015
Primary Completion:	April 12, 2018 [Anticipated]
Study Completion:	October 13, 2021 [Anticipated]

First Submitted:	March 30, 2015
First Submitted that Met QC Criteria:	March 30, 2015
First Posted:	April 2, 2015 [Estimate]

Last Update Submitted that Met QC Criteria:	April 20, 2017
Last Update Posted:	April 21, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	Janssen Research & Development, LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Detailed Description:

This is a Phase 3, randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), multi-center (more than one clinical site will work on a medical research study), protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.

Conditions


Conditions:	Colitis, Ulcerative Inflammatory Bowel Diseases
Keywords:	Ustekinumab Inflammatory Bowel Diseases (IBD) Colitis, Ulcerative

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	10
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	951 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Placebo Comparator: Induction Study - Placebo Intravenous (IV) Participants will be randomized to receive single dose of placebo as Intravenous (IV: into the vein) infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study, but will not be randomized.	Drug: Placebo IV Placebo will be administered as intravenous infusion.
Experimental: Induction Study - Ustekinumab 130 milligram (mg) IV Participants will be randomized to receive single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.	Drug: Ustekinumab IV Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Experimental: Induction Study - Ustekinumab 6 mg/kg IV Participants will be randomized to receive ustekinumab approximating 6 mg/kg of body weight, as intravenous infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.	Drug: Ustekinumab IV Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction Study- Placebo- Nonresponsders at Week 8 Participants without clinical response to placebo at Week 8 will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo (to maintain the blind). Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized.	Drug: Ustekinumab IV Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction study-Ustekinumab Nonresponders at Week 8 Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) at Week 8 will receive a single dose of ustekinumab 90 mg subcutaneously along with matching placebo intravenously (to maintain the blind). Participants in clinical response at Week 16 (that is, delayed responders) will be eligible to enter Maintenance study, but will not be randomized.	Drug: Ustekinumab SC Ustekinumab will be administered as subcutaneously.
Placebo Comparator: Maintenance Study - Placebo Subcutaneous (SC) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	Drug: Placebo SC Placebo will be administered Subcutaneously.
Experimental: Maintenance Study - Ustekinumab 90mg SC every 12 weeks Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 12 weeks, beginning Week 0 of Maintenance study through Week 44.	Drug: Ustekinumab SC Ustekinumab will be administered as subcutaneously.
Experimental: Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44.	Drug: Ustekinumab SC Ustekinumab will be administered as subcutaneously.
Maintenance Study - Placebo IV - Responder - Placebo SC Participants in clinical response to Induction treatment with IV Placebo will receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.	Drug: Placebo SC Placebo will be administered Subcutaneously.
Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w Participants without clinical response to induction treatment ustekinumab (130 mg or 6 mg/kg [IV]) at Week 8 but in clinical response at Week 16 after receiving Induction Ustekinumab at week 8 (delayed responders) will receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.	Drug: Ustekinumab SC Ustekinumab will be administered as subcutaneously.

Outcome Measures


Primary Outcome Measures:
1.	Induction Study - Number of Participants With Clinical Remission [ Time Frame: Week 8 ] The global definition of Clinical remission is defined as Mayo score less than or equal to (<=) 2 points, with no individual subscore greater than (>) 1, for countries outside the United States (US). For the US, Clinical remission is defined as absolute stool number <=3, a rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
2.	Maintenance Study - Number of Participants with Clinical Remission Among Participants in Clinical Response to IV Ustekinumab Induction Treatment [ Time Frame: Week 44 ] The global definition of Clinical remission is defined as Mayo score less than or equal to (<=) 2 points, with no individual subscore greater than (>) 1, for countries outside the United States (US). For the US Clinical remission is defined as absolute stool number <=3, a rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Secondary Outcome Measures:
1.	Induction Study - Number of Participants with Clinical Response [ Time Frame: Week 8 ] Clinical response is defined as a decreased from Induction baseline in the Mayo score by greater than or equal to (>=) 30 percent (%) and >=3 points, with either a decrease from induction baseline in the rectal bleeding subscore >=1 or rectal bleeding subscore = 0 or 1.
2.	Induction Study - Number of Participants With Endoscopic Healing [ Time Frame: Week 8 ] Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It will be defined as Mayo endoscopic subscore = 0 or 1.
3.	Induction Study - Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Week 8 ] The IBDQ is a 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel (loose stools, abdominal pain), systemic (fatigue, altered sleep pattern), social (work attendance, need to cancel social events), and emotional (anger, depression, irritability). The total score ranges from 32 to 224 with higher scores indicating better quality of life.
4.	Maintenance Study - Number of Participants with Clinical Response Among Participants in Clinical Response to IV Ustekinumab Induction Treatment [ Time Frame: Through Week 44 ] Clinical response is defined as a decreased from Induction baseline in the Mayo score by greater than or equal to (>=) 30 percent (%) and >=3 points, with either a decrease from Induction baseline in the rectal bleeding subscore >=1 or rectal bleeding subscore = 0 or 1.
5.	Maintenance Study - Number of Participants with Endoscopic Healing Among Participants in Clinical Response to IV Ustekinumab Induction Treatment [ Time Frame: Week 44 ] Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It will be defined as Mayo endoscopic subscore = 0 or 1.
6.	Maintenance Study - Number of Participants with Clinical Remission Among those who Achieved Clinical Remission at Maintenance Study Baseline [ Time Frame: Through Week 44 ] The global definition of Clinical remission is defined as Mayo score less than or equal to (<=) 2 points, with no individual subscore greater than (>) 1, for countries outside the United States (US). For the US Clinical remission is defined as absolute stool number <=3, a rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis.
7.	Maintenance Study - Number of Participants with Clinical Remission and not Receiving Concomitant Corticosteroids Among those Receiving Concomitant Corticosteroids at Maintenance Baseline [ Time Frame: Week 44 ] The global definition of Clinical remission is defined as Mayo score less than or equal to (<=) 2 points, with no individual subscore greater than (>) 1, for countries outside the United States (US). For the US Clinical remission is defined as absolute stool number <=3, a rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC) Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks Exclusion Criteria: Has severe extensive colitis and is at imminent risk of colectomy Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon Presence of a stoma or history of a fistula Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Contacts/Locations


Central Contact Person:	Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: Email: JNJ.CT@sylogent.com
Study Officials:	Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Locations:	United States, Alabama
	University of Alabama Liver Center [Recruiting] Birmingham, Alabama, United States, 35294
	Mobile Medical And Diagnostic Center [Withdrawn] Mobile, Alabama, United States, 36617
	United States, Arizona
	Adobe Clinical Research LLC [Withdrawn] Tucson, Arizona, United States, 85712
	United States, California
	Scripps Clinic La Jolla [Withdrawn] La Jolla, California, United States, 92037
	Biovin Enterprises LLC dba Medvin Clinical Research [Recruiting] La Mirada, California, United States, 90638
	Cedars Sinai Medical Center [Recruiting] Los Angeles, California, United States, 90048
	Surinder Saini M.D., Inc [Recruiting] Newport Beach, California, United States, 92660
	Weisman Medical Group [Withdrawn] Palo Alto, California, United States, 94304
	South Bay Gastroenterology [Recruiting] Torrance, California, United States, 90505
	Vallejo Hospital and Medical Offices [Recruiting] Vallejo, California, United States, 94589
	United States, Colorado
	South Denver, PC [Recruiting] Lone Tree, Colorado, United States, 80124
	United States, Connecticut
	Connecticut Gastroenterology Institute at Bristol Hospital [Withdrawn] Bristol, Connecticut, United States, 06010
	Connecticut GI [Recruiting] Farmington, Connecticut, United States, 06032
	Chase Medical Research LLC [Withdrawn] Waterbury, Connecticut, United States, 06708
	United States, District of Columbia
	Georgetown Univ Hospital [Recruiting] Washington, D.C., District of Columbia, United States, 20007
	United States, Florida
	Zasa Clinical Research [Withdrawn] Atlantis, Florida, United States, 33462
	Clinical Trials Management of Boca Raton Inc. [Withdrawn] Boca Raton, Florida, United States, 33428
	University of Florida [Recruiting] Gainesville, Florida, United States, 32610
	Florida Center For Gastroenterology [Recruiting] Largo, Florida, United States, 33777
	A Plus Research [Recruiting] Miami, Florida, United States, 33144
	Advanced Medical Research Center [Recruiting] Port Orange, Florida, United States, 32127
	Univ. of South Florida Med. Group [Recruiting] Tampa, Florida, United States, 33606
	Shafran Gastroenterology Center [Recruiting] Winter Park, Florida, United States, 32789
	Florida Medical Clinic, P.A. [Recruiting] Zephyrhills, Florida, United States, 33542
	United States, Georgia
	Emory University [Recruiting] Atlanta, Georgia, United States, 30322
	Atlanta Gastroenterology Associates [Recruiting] Atlanta, Georgia, United States, 30342
	Atlanta Center For Gastroenterology [Recruiting] Decatur, Georgia, United States, 30033
	Gastroenterolgy Associates of Central GA [Recruiting] Macon, Georgia, United States, 31201
	Atlanta Gastroenterology Specialists, PC [Recruiting] Suwanee, Georgia, United States, 30024
	United States, Idaho
	Grand Teton Gastroenterology [Recruiting] Idaho Falls, Idaho, United States, 83404
	United States, Illinois
	Northwest Gastroenterologists S.C. [Withdrawn] Arlington Heights, Illinois, United States, 60005
	Rush University Medical Center [Recruiting] Chicago, Illinois, United States, 60612
	NorthShore University Health System, Evanston Hospital [Recruiting] Evanston, Illinois, United States, 60201
	Loyola University Medical Center [Not yet recruiting] Maywood, Illinois, United States, 60153
	Digestive Health Research Center - The Carle Foundation [Suspended] Urbana, Illinois, United States, 61801
	United States, Indiana
	Indianapolis Gastroenterology Research Foundation [Recruiting] Indianapolis, Indiana, United States, 46237
	United States, Iowa
	University of Iowa Hospital and Clinic [Withdrawn] Iowa City, Iowa, United States, 52242
	United States, Kansas
	Health Science Research Center [Recruiting] Pratt, Kansas, United States, 67124
	United States, Kentucky
	Tri-State Gastroenterology Assoc [Recruiting] Crestview Hills, Kentucky, United States, 41017
	University of Kentucky [Recruiting] Lexington, Kentucky, United States, 40506
	University of Louisville-627 South Preston Street [Recruiting] Louisville, Kentucky, United States, 40202
	United States, Louisiana
	Houma Digestive Health Specialists LLC [Recruiting] Houma, Louisiana, United States, 70360
	Louisiana Research Center [Recruiting] Shreveport, Louisiana, United States, 71103
	United States, Maryland
	Gastro Center Of Maryland [Recruiting] Columbia, Maryland, United States, 21045
	United States, Massachusetts
	Massachusetts General Hospital_Boston [Recruiting] Boston, Massachusetts, United States, 02114
	United States, Michigan
	University of Michigan [Recruiting] Ann Arbor, Michigan, United States, 48109
	Clinical Research Institute of Michigan, LLC [Recruiting] Chesterfield, Michigan, United States, 48047
	Center for Digestive Health [Withdrawn] Troy, Michigan, United States, 48098
	Center for Digestive Health [Recruiting] Troy, Michigan, United States, 48098
	Saint Joseph Mercy Hospital [Recruiting] Ypsilanti, Michigan, United States, 48197
	United States, Minnesota
	Mayo Clinic [Recruiting] Rochester, Minnesota, United States, 55905
	United States, Mississippi
	University of Mississippi Medical Center [Recruiting] Jackson, Mississippi, United States, 39216
	United States, Missouri
	Washington University School of Medicine [Withdrawn] Saint Louis, Missouri, United States, 63110
	United States, New Jersey
	South Jersey Gastroenterology [Recruiting] Marlton, New Jersey, United States, 08053
	Morristown Memorial [Recruiting] Morristown, New Jersey, United States, 07962
	United States, New York
	Albany Medical Center [Withdrawn] Albany, New York, United States, 12208
	NY Scientific [Recruiting] Brooklyn, New York, United States, 11235
	Winthrop University Hospital [Recruiting] Mineola, New York, United States, 11501
	Beth Israel Medical Center [Withdrawn] New York, New York, United States, 10003
	Manhattan Medical Research [Withdrawn] New York, New York, United States, 10016
	New York University Langone Medical Center [Recruiting] New York, New York, United States, 10016
	NYU Langone Long Island Clinical Research Associates [Recruiting] New York, New York, United States, 10016
	Weill Medical College of Cornell University [Recruiting] New York, New York, United States, 10021
	Columbia University Medical Center [Recruiting] New York, New York, United States, 10032
	Lenox Hill Hospital [Recruiting] New York, New York, United States, 10075
	Premier Medical Group of the Hudson Valley [Recruiting] Poughkeepsie, New York, United States, 12601
	University of Rochester [Recruiting] Rochester, New York, United States, 14642
	Stony Brook University Medical Center - NY [Withdrawn] Stony Brook, New York, United States, 11794
	Montefiore Medical Center [Suspended] The Bronx, New York, United States, 10467
	United States, Ohio
	Greater Cincinnati Gastroenterology Association, Inc. [Recruiting] Cincinnati, Ohio, United States, 45219
	Great Lakes Gastroenterology [Recruiting] Mentor, Ohio, United States, 44060
	United States, Oklahoma
	Oklahoma Foundation for Digestive Research [Withdrawn] Oklahoma City, Oklahoma, United States, 73102
	United States, Oregon
	Northwest Gastroenterology Clinic [Recruiting] Portland, Oregon, United States, 97210
	United States, Pennsylvania
	Central Bucks Specialists [Recruiting] Doylestown, Pennsylvania, United States, 18901
	Penn State Hershey Medical Center [Not yet recruiting] Hershey, Pennsylvania, United States, 17033
	University of Pennsylvania - Perelman School of Medicine [Recruiting] Philadelphia, Pennsylvania, United States, 19104
	Jefferson Digestive Disease Service [Withdrawn] Philadelphia, Pennsylvania, United States, 19107
	Temple University Hospital [Recruiting] Philadelphia, Pennsylvania, United States, 19140
	Guthrie Medical Group, PC [Recruiting] Sayre, Pennsylvania, United States, 18840
	United States, South Carolina
	Southeast Medical Research [Withdrawn] North Charleston, South Carolina, United States, 29406
	United States, Tennessee
	Chattanooga Medical Research [Withdrawn] Chattanooga, Tennessee, United States, 37404
	Gastro One [Recruiting] Germantown, Tennessee, United States, 38138
	Quality Medical Research Nashville [Completed] Nashville, Tennessee, United States, 37211
	Vanderbilt [Recruiting] Nashville, Tennessee, United States, 37232
	United States, Texas
	Austin Gastroenterology, PA [Withdrawn] Austin, Texas, United States, 78745
	Research Concepts [Withdrawn] Bellaire, Texas, United States, 77401
	Texas Digestive Disease Consultants [Recruiting] Dallas, Texas, United States, 75231
	Brooke Army Medical Center [Not yet recruiting] Fort Sam Houston, Texas, United States, 78234
	Baylor College of Medicine-Univ. Hosp. [Recruiting] Houston, Texas, United States, 77030
	Houston Methodist Hospital [Recruiting] Houston, Texas, United States, 77030
	The University Of Texas Medical School At Houston [Recruiting] Houston, Texas, United States, 77030
	Texas Digestive Disease [Recruiting] Irving, Texas, United States, 75039
	Darnall Army Comm Hospital Internal Medicine [Withdrawn] Killeen, Texas, United States, 76544
	Gastroenterology Clinic Of San Antonio P A [Recruiting] San Antonio, Texas, United States, 78229
	University of Texas Health Science Center - Medical Education [Withdrawn] San Antonio, Texas, United States, 78229
	Texas Digestive Disease Consultants [Recruiting] Southlake, Texas, United States, 76092
	Digestive Health Specialists of Tyler [Recruiting] Tyler, Texas, United States, 75701
	United States, Utah
	Aspen Clinical Research [Withdrawn] Orem, Utah, United States, 84058
	Wasatch Clinical Research [Recruiting] Salt Lake City, Utah, United States, 84102
	Advanced Clinical Research [Recruiting] West Jordan, Utah, United States, 84088
	Advanced Clinical Research [Withdrawn] West Jordan, Utah, United States, 84088
	United States, Vermont
	University Of Vermont - Fletcher Allen Healthcare [Withdrawn] Burlington, Vermont, United States, 05401
	United States, Virginia
	Gastroenterology Associates of Tidewater [Recruiting] Chesapeake, Virginia, United States, 23320
	Gastroenterology Associates of Northern Virginia [Recruiting] Fairfax, Virginia, United States, 22031
	Carilion Clinic-Dept.of Med. [Recruiting] Roanoke, Virginia, United States, 24016
	United States, Washington
	Virginia Mason Medical Center [Recruiting] Seattle, Washington, United States, 98101
	University of Washington [Recruiting] Seattle, Washington, United States, 98195
	UW Medicine - Harborview Medical Center [Recruiting] Seattle, Washington, United States, 98195
	Australia
	University of NSW - Bankstown-Lidcombe Hospital [Withdrawn] Bankstown, Australia, 2200
	Flinders Medical Centre [Completed] Bedford, Australia, 5042
	BOX HILL [Withdrawn] Box Hill, Australia, 3128
	Nambour General Hospital [Withdrawn] Central Queensland M C, Australia, 4560
	Monash Health, Monash Medical Centre [Recruiting] Clayton, Australia, 3168
	Concord Hospital [Recruiting] Concord N/A, Australia, 2137
	Saint Vincent's Hospital - Melbourne [Recruiting] Fitzroy, Australia, 3065
	Centre For Digestive Diseases [Completed] Five Dock, Australia, 2046
	Canberra Hospital - Australia [Recruiting] Garran, Australia, 2605
	Austin Hospital [Recruiting] Heidelberg, Australia, 3084
	Liverpool Hospital [Recruiting] Liverpool, Australia, 2170
	The Alfred Hospital - Clinical Research Unit - Infectious Diseases [Recruiting] Melbourne, Australia, 3004
	Royal Melbourne [Withdrawn] Parkville, Australia
	Mater Hospital Brisbane [Recruiting] South Brisbane, Australia, 4101
	Austria
	Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III [Recruiting] Salzburg, Austria, 5020
	Krankenhaus der Barmherzigen Brueder St. Veit [Withdrawn] St Veit An Der Glan, Austria, 9300
	Akh Wien [Recruiting] Wien, Austria, 1090
	Hartmannspital [Withdrawn] Wien, Austria, A-1050
	Belgium
	GZA Ziekenhuizen [Recruiting] Antwerpen, Belgium, 2018
	UZ Gent [Recruiting] Gent, Belgium, 9000
	Az Groeninge [Recruiting] Kortrijk, Belgium, 8500
	University Hospitals Leuven [Recruiting] Leuven, Belgium, 3000
	UZ Leuven [Recruiting] Leuven, Belgium, 3000
	CHC-Cliniques Saint-Joseph [Recruiting] Liège, Belgium, 4000
	CHU de Liège [Recruiting] Liège, Belgium, 4000
	AZ Delta VZW [Recruiting] Roeselaere, Belgium, 8800
	Bulgaria
	University Multiprofile Hospital for Active Treatment - UMHAT Dr. Georgi Stranski [Recruiting] Pleven, Bulgaria, 5800
	MHAT Rousse [Recruiting] Rousse, Bulgaria, 7002
	Medical Center-1-Sevlievo EOOD [Recruiting] Sevlievo, Bulgaria, 5400
	2nd MHAT [Recruiting] Sofia, Bulgaria, 1202
	St. Ivan Rilski Hospital [Recruiting] Sofia, Bulgaria, 1431
	MHAT Tokuda Hospital Sofia [Recruiting] Sofia, Bulgaria, 1527
	Medical Center Asklepion [Recruiting] Sofia, Bulgaria, 1606
	MHAT 'Doverie' [Gastroenterology] [Recruiting] Sofia, Bulgaria, 1632
	MC "Synexus Sofia" EOOD [Recruiting] Sofia, Bulgaria, 1784
	Medical Center Mladost Med 1 [Recruiting] Sofia, Bulgaria, 1784
	MHAT St Marina [Recruiting] Varna, Bulgaria, 9010
	Canada, British Columbia
	GIRI Gastrointestinal Research Institute [Recruiting] Vancouver, British Columbia, Canada, V6Z 2K5
	PerCuro Clinical Research Ltd. [Recruiting] Victoria, British Columbia, Canada, V8V 3M9
	Canada, Manitoba
	Brandon Medical Arts Clinic [Recruiting] Brandon, Manitoba, Canada, R7A 0N7
	Winnipeg Health Sciences Centre [Recruiting] Winnipeg, Manitoba, Canada, R3A 1R9
	Canada, Ontario
	London Health Sciences Centre - University Campus [Recruiting] London, Ontario, Canada, N6A 5A5
	London Health Sciences Center [Recruiting] London, Ontario, Canada, N6A 5W9
	Office of Kimberley S. Tilbe, MD [Recruiting] Sudbury, Ontario, Canada, P3C 5N3
	Canada, Quebec
	Maisonneuve-Rosemont - Gastroenterology [Not yet recruiting] Montreal, Quebec, Canada, H1T 2M4
	McGill University - Health Centre - Montreal General Hospital [Recruiting] Montreal, Quebec, Canada, H3G 1A4
	Czechia
	Hepato-gastroenterologie HK s.r.o. [Recruiting] Hradec Kralove, Czechia, 500 12
	Fakultni nemocnice Plzen [Recruiting] Plzen, Czechia, 304 60
	IKEM [Recruiting] Prague 4, Czechia, 140 21
	Fakultni nemocnice v Motole [Recruiting] Praha 5, Czechia, 150 06
	ISCARE I.V.F. a.s. [Recruiting] Praha 7, Czechia, 170 04
	NH Hospital, a.s. [Withdrawn] Praha 8, Czechia, 180 81
	Medicon a.s. [Recruiting] Praha 9, Czechia, 190 00
	Denmark
	Aarhus Universitetshospital [Recruiting] Aarhus, Denmark, 8000
	Odense Universitetshospital [Recruiting] Odense, Denmark, 5000
	France
	CHU Amiens-Hopital Nord [Recruiting] Amiens, France, 80054
	CHU de Bordeaux - Hôpital Saint André [Recruiting] Bordeaux, France, 33076
	CHRU de Lille - Hôpital Claude Huriez [Recruiting] Lille, France, 59037
	Clinique de la Sauvegarde [Recruiting] Lyon, France, 69009
	Aphm - Hopital Nord [Recruiting] Marseille, France, 13915
	CHRU Montpellier - Hopital Saint-Eloi [Recruiting] Montpellier, France, 34295
	Hopital Saint-Antoine [Withdrawn] Paris, France, 75012
	Hôpital Necker [Withdrawn] Paris, France, 75743
	CHU Lyon Sud [Recruiting] Pierre-Benite, France, 69495
	Hôpital Robert Debré [Recruiting] Reims, France, 51092
	CHRU Hôpital de Pontchaillou [Recruiting] Rennes, France, 35033
	CHU Hôpital Nord [Recruiting] Saint-Etienne, France, 42055
	Hopital de Rangueil [Recruiting] Toulouse, France, 31059
	Germany
	Universitaetsklinikum Charite, Campus Virchow Klinikum [Recruiting] Berlin, Germany, 13353
	Klinikum Dresden [Not yet recruiting] Dresden, Germany, 01307
	St Josef Krankenhaus [Recruiting] Essen, Germany, 45257
	Universitatsklinikum Freiburg [Recruiting] Freiburg, Germany, 79106
	Medizinische Hochschule Hannover [Recruiting] Hannover, Germany, 30625
	Universitaetsklinikum Schleswig-Holstein Campus Kiel [Recruiting] Kiel, Germany, 24105
	Gastroenterologie und Hepatologie am Johannisplatz [Recruiting] Leipzig, Germany, 04103
	Städtisches Klinikum Lüneburg [Recruiting] Lüneburg, Germany, 21339
	Medizinische Fakultät Mannheim der Universität Heidelberg [Recruiting] Mannheim, Germany, 68167
	Gastroenterologische Gemeinschaftspraxis Minden [Recruiting] Minden, Germany, 32423
	MVZ Portal 10 [Recruiting] Münster, Germany, 48155
	Gemeinschaftspraxis Germania-Campus [Completed] Münster, Germany, 48159
	Hungary
	DRC Gyógyszervizsgáló Központ Kft. [Recruiting] Balatonfüred, Hungary, H-8230
	Semmelweis Egyetem [Recruiting] Budapest, Hungary, 1088
	Pannónia Magánorvosi Centrum Kft [Recruiting] Budapest, Hungary, 1136
	Réthy Pál Kórház-Rendelointézet [Recruiting] Békéscsaba, Hungary, 5600
	Vasútegészségügyi Nonprofit Közhasznú Kft., Debreceni Egészs [Recruiting] Debrecen, Hungary, 4025
	Debreceni Egyetem Klinikai Központ [Recruiting] Debrecen, Hungary, H-4012
	Miskolci Semmelweis Kórház és Egyetemi Oktatókórház [Completed] Miskolc, Hungary, 3529
	Karolina Korhaz-Rendelointezet [Recruiting] Mosonmagyarovar, Hungary, 9200
	Tolna Megyei Önkormányzat Balassa János Kórháza [Recruiting] Szekszárd, Hungary, 7100
	Vas Megyei Markusovszky Lajos Általános Rehabilitációs [Recruiting] Szombathely, Hungary, H-9700
	Fejér Megyei Szent György Kórház I. Sz. Belgyógyászat [Recruiting] Székesfehérvár, Hungary, 8000
	Jávorszky Ödön Kórház [Completed] Vac, Hungary, 2600
	Israel
	Ha'Emek Medical Center [Not yet recruiting] Afula, Israel, 18101
	Soroka University Medical Center [Recruiting] Beersheba, Israel, 84101
	Bnai Zion Medical Center [Recruiting] Haifa, Israel, 31048
	The Edith Wolfson Medical Center [Recruiting] Holon, Israel, 58100
	Shaare Zedek Medical Center [Recruiting] Jerusalem, Israel, 91031
	Meir Medical Center [Recruiting] Kfar-Saba, Israel, 44281
	Western Galilee Hospital [Recruiting] Nahariya, Israel, 22100
	Rabin Medical Center, Beilinson Hospital [Recruiting] Petach Tikvah, Israel, 49100
	Tel Aviv Sourasky Medical Center [Recruiting] Tel Aviv, Israel, 64239
	The Chaim Sheba Medical Center [Recruiting] Tel Hashomer, Israel, 52621
	Japan
	Ohmori Toshihide Gastrointestinal Clinic [Recruiting] Ageo-Shi, Japan, 362-0075
	Asahikawa City Hospital [Recruiting] Asahikawa, Japan, 070-8610
	Tokyo Medical and Dental University Hospital [Recruiting] Bunkyo-Ku, Japan, 113-8519
	Chiba University Hospital [Recruiting] Chiba, Japan, 260-8677
	Fukuoka University Chikushi Hospital [Recruiting] Chikushinoshi, Japan, 818-8502
	Sai Gastroenterology, Proctology [Recruiting] Fujiidera, Japan, 583-0027
	Kitakyushu Municipal Medical Center [Recruiting] Fukuoka-Ken, Japan, 802-0077
	Mito Medical Center [Recruiting] Higashi-Ibaraki, Japan, 311-3193
	Hirosaki National Hospital [Recruiting] Hirosaki, Japan, 036-8545
	Hiroshima University Hospital [Recruiting] Hiroshima, Japan, 734-8551
	Isesaki Municipal Hospital [Recruiting] Isesaki, Japan, 372-0817
	Iwate Medical University Hospital [Recruiting] Iwate, Japan, 020-8505
	Shimane University Hospital [Recruiting] Izumo, Japan, 693-8501
	Kagawa Prefectural Central Hospital [Recruiting] Kagawa, Japan, 760-8557
	Sameshima Hospital [Recruiting] Kagoshima, Japan, 892-0846
	Nanpuh Hospital [Recruiting] Kagoshima, Japan, 892-8512
	Kanazawa Medical University Hospital [Recruiting] Kahoku, Japan, 920-0293
	Ibaraki Prefectural Central Hospital [Withdrawn] Kasama, Japan, 309-1703
	Aoyama Naika Clinic [Recruiting] Kobe-Shi, Japan
	Kochi National Hospital [Recruiting] Kochi, Japan, 780-8077
	Kurume University Hospital [Recruiting] Kurume, Japan, 830-0011
	Hidaka Coloproctologic Clinic [Recruiting] Kurume, Japan, 839-0809
	NHO Kyoto Medical Center [Recruiting] Kyoto, Japan, 612-8555
	Tokitokai Tokito Clinic Coloproctology Center [Recruiting] Midori-Ku, Japan, 336-0963
	Nagasaki University Hospital [Recruiting] Nagasaki, Japan, 852-8102
	Kenseikai Dongo Hospital [Recruiting] Nara, Japan, 635-0022
	Hyogo College of Medicine Hospital [Recruiting] Nishinomiya, Japan, 663-8501
	Oita Red Cross Hospital [Recruiting] Oita, Japan, 870-0033
	Osaka City General Hospital [Recruiting] Osaka, Japan, 534-0021
	Osaka City University Hospital [Recruiting] Osaka, Japan, 545-8586
	Saga University Hospital [Recruiting] Saga, Japan, 849-8501
	Kojinkai Himeji Central Hospital [Recruiting] Saga-Ken, Japan
	Tenmakai Chikuba Hospital [Recruiting] Saitama, Japan, 362-0075
	Toho University Sakura Medical Center [Recruiting] Sakura, Japan, 285-8741
	Sapporo Kosei General Hospital [Recruiting] Sapporo, Japan, 060-0033
	KKR Sapporo Medical Center [Recruiting] Sapporo, Japan, 062-0931
	National Hospital Organization Sendai Medical Center [Recruiting] Sendai, Japan, 983-8520
	Matsuda Hospital [Recruiting] Shizuoka, Japan, 432-8061
	Shizuoka Medical Center [Recruiting] Sunto-Gun, Japan, 411-8611
	Takamatsu Red Cross Hospital [Recruiting] Takamatsu, Japan, 760-0017
	The Jikei University Hospital [Withdrawn] Tokyo, Japan, 105-8471
	Kitasato Institute Hospital Biomedical Research Center, Clinical Trial Unit [Recruiting] Tokyo, Japan, 108-8642
	Juntendo University Hospital [Recruiting] Tokyo, Japan, 113-8431
	NTT Medical Center Tokyo [Recruiting] Tokyo, Japan, 141-8625
	Kyorin University Hospital [Recruiting] Tokyo, Japan, 600-8492
	Saiseikai Toyama Hospital [Recruiting] Toyama, Japan, 931-8533
	Ieda Hospital [Recruiting] Toyota, Japan, 470-1219
	Mie University Hospital [Recruiting] Tsu, Japan, 514-8507
	JA Tsuchiura Kyodo General Hospital [Recruiting] Tsuchiura, Japan, 300-0053
	Wakayama Medical University Hospital [Recruiting] Wakayama, Japan, 641-8510
	Yamanashi Prefectural Central Hospital [Recruiting] Yamanashi, Japan, 400-8506
	Korea, Republic of
	Keimyung University Dongsan Medical Center [Recruiting] Daegu, Korea, Republic of, 700-712
	Kyungpook National University Hospital [Recruiting] Daegu, Korea, Republic of, 700-721
	Hanyang Unviersity Guri Hospital [Completed] Guri-Si, Korea, Republic of, 471-701
	Asan Medical Center [Recruiting] Seoul, Korea, Republic of, 05505
	Kyung Hee University Medical Center [Recruiting] Seoul, Korea, Republic of, 102-1703
	Severance Hospital, Yonsei University Health System [Recruiting] Seoul, Korea, Republic of, 120-752
	Samsung Medical Center [Recruiting] Seoul, Korea, Republic of, 135-710
	The Catholic University of Korea [Recruiting] Suwon-Si, Korea, Republic of, 16247
	Netherlands
	Academisch Medisch Centrum Universiteit van Amsterdam [Recruiting] Amsterdam, Netherlands, 1105 AZ
	Academisch Ziekenhuis Maastricht [Recruiting] Maastricht, Netherlands, 6229 HX
	New Zealand
	Auckland City Hospital [Recruiting] Auckland, New Zealand, 1142
	Christchurch Hospital [Recruiting] Christchurch, New Zealand, 8140
	Dunedin Hospital [Recruiting] Dunedin, New Zealand, 9016
	Hutt Hospital [Recruiting] Lower Hutt, New Zealand, 5010
	Shakespeare Specialist Group Ian Wallace Ltd [Completed] Milford, New Zealand, 0620
	Poland
	Copernicus Podmiot Leczniczy Sp z o. o [Completed] Gdansk, Poland, 80-462
	5 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ [Completed] Krakow, Poland, 30-901
	Szpital Uniwersytecki w Krakowie [Withdrawn] Krakow, Poland, 31-531
	Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego [Recruiting] Lodz, Poland, 90-153
	Centrum Medyczne Med-Gastr [Recruiting] Lodz, Poland, 91-034
	KO-MED Centra Kliniczne Puławy [Recruiting] Pulawy, Poland, 24-100
	Endoskopia Sp z o.o. [Recruiting] Sopot, Poland, 81-756
	Twoja Przychodnia - Szczecinskie Centrum Medyczne [Not yet recruiting] Szczecin, Poland, 71-270
	Centrum Badawcze Wspolczesnej Terapii [Recruiting] Warszawa, Poland, 01-337
	Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie [Recruiting] Warszawa, Poland, 02-781
	NZOZ Vivamed Zespol Lekarzy Specjalistow [Recruiting] Warszawa, Poland, 03 580
	Melita Medical [Recruiting] Wroclaw, Poland, 50-449
	Lexmedica [Recruiting] Wroclaw, Poland, 53-025
	ARS MEDICA Rybak Maria, Rybak Zbigniew, s.c. [Recruiting] Wroclaw, Poland, 53-333
	Romania
	MedLife Grivita [Recruiting] Bucuresti, Romania, 010719
	Centrul Medical SANA [Recruiting] Bucuresti, Romania, 011025
	Spitalul Universitar de Urgenta Bucuresti [Recruiting] Bucuresti, Romania, 050098
	Spitalul Universitar de Urg Militar Central Dr.Carol Davila [Recruiting] Bucuresti, Romania, 050728
	Cabinet Medical Dr Fratila [Recruiting] Oradea, Romania, 410167
	Centrul Medical de Diagnostic, Tratament Ambulator si Medicina Preventiva Bucurest [Completed] Romania, Romania, 061911
	Cabinet Particular Policlinic Algomed [Recruiting] Timisoara, Romania, 300002
	Med Life [Recruiting] Timisoara, Romania, 300166
	Russian Federation
	Scientific Centre for Reconstructive and Restorative Surgery [Recruiting] Irkutsk, Russian Federation, 664003
	Kazan State Medical University [Recruiting] Kazan, Russian Federation, 420012
	Central Clinical Hospital of RAS [Recruiting] Moscow, Russian Federation, 117593
	Central Clinical Hospital of RAS [Recruiting] Moscow, Russian Federation, 119333
	City Clinical Hospital #51 [Withdrawn] Moscow, Russian Federation, 121309
	GU "Moscow Regional Research Clinical Institute n.a. M.F.Vla [Recruiting] Moscow, Russian Federation, 129110
	Novosibirsk State Medical University [Recruiting] Novosibirsk, Russian Federation, 630091
	Federal State Budgetary Institution "Scientific Research Institute" [Recruiting] Novosibirsk, Russian Federation, 630117
	Omsk state medical academy [Withdrawn] Omsk, Russian Federation, 644099
	City Hospital #20 [Recruiting] Rostov-On-Don, Russian Federation, 344091
	Ryazan Regional Clinical Hospital [Recruiting] Ryazan, Russian Federation, 390039
	Military Medical Academy [Recruiting] Saint Petersburg, Russian Federation, 191015
	Elizavetinskaya hospital [Recruiting] Saint Petersburg, Russian Federation, 195257
	City Clinical Hospital # 26 [Recruiting] St Petersburg, Russian Federation, 196247
	Northen-Western State Medical University n.a. I.I. Mechnikov [Recruiting] St.-Petersburg, Russian Federation, 195067
	Stavropol State Medical University (StSMU) - State Institution Clinic of Mental Disorders Borderline [Recruiting] Stavropol, Russian Federation, 355017
	City Clinical Hospital # 21 [Recruiting] Ufa, Russian Federation, 450071
	Serbia
	Clinical Center Serbia [Recruiting] Belgrade, Serbia, 11 000
	Zvezdara University Medical Center [Recruiting] Belgrade, Serbia, 11000
	Clinical Center Zemun [Withdrawn] Belgrade, Serbia, 11080
	Clinical Hospital Center Bezanijska Kosa [Recruiting] Belgrade, Serbia, 11080
	Clinical Center of Kragujevac [Recruiting] Kragujevac, Serbia, 34000
	Clinical Center Nis [Recruiting] Nis, Serbia, 18000
	Clinical Center of Vojvodina [Recruiting] Vojvodina, Serbia, 21000
	Slovakia
	IBDcentrum s.r.o. [Recruiting] Bratislava, Slovakia, 831 04
	GASTRO I. s.r.o. [Recruiting] Presov, Slovakia, 080 01
	UVN SNP Ruzomberok - FN [Withdrawn] Ruzomberok, Slovakia, 034 26
	Ukraine
	Bukovinian State Medical University [Not yet recruiting] Chernivtsi, Ukraine, 58001
	Dnipropetrovska derzhavna medychna akademiya [Recruiting] Dnipropetrovsk, Ukraine, 49044
	Ivano-Frankivsk National Medical University [Recruiting] Ivano-Frankivsk, Ukraine, 76008
	KZOZ Kharkivska miska klinichna likarnia #13 [Recruiting] Kharkiv, Ukraine, 61035
	Kharkiv City Clinical Hospital [Recruiting] Kharkiv, Ukraine, 61037
	Kyiv Regional Clinical Hospital [Recruiting] Kiyv, Ukraine, 04107
	Kyivska miska klinichna likarnia 18 [Recruiting] Kyiv, Ukraine, 01030
	Natsionalna medychna akademiia pisliadyplomnoi osvity imeni [Recruiting] Kyiv, Ukraine, 04201
	Danylo Halytsky Lviv National Medical University [Recruiting] Lviv, Ukraine, 79010
	Lvivskyi natsionalnyi medychnyi uni. imeni D. Galytskogo [Recruiting] Lviv, Ukraine, 79010
	Odeska oblasna klinichna likarnia [Recruiting] Odessa, Ukraine, 65025
	Komunalnyi zaklad Sumskoi oblasnoi rady " sumska oblasna kli [Recruiting] Sumy, Ukraine, 40022
	Transcarpathian Regional Clinical Hospital [Recruiting] Uzhgorod, Ukraine, 88000
	Vinnytska Oblasna klinichna likarnia imeni M.I [Recruiting] Vinnytsia, Ukraine, 21018
	Pryv male pidpr, medychnyi tsentr 'Puls' [Recruiting] Vinnytsia, Ukraine, 21029
	Slaomed- Khels-Klinik [Recruiting] Vinnytsia, Ukraine, 21029
	KU 6 miska klinichna likarnia ZMR [Recruiting] Zaporizhzhia, Ukraine, 69035
	Miska likarnia №7 [Recruiting] Zaporizhzhia, Ukraine, 69118
	Zaporizhzhia Medical University [Recruiting] Zhaporozhia, Ukraine, 69000
	United Kingdom
	Tameside Hosptial NHS Foundation Trust [Withdrawn] Ashton Under Lyne, United Kingdom, OL6 9RW
	Queen Elizabeth Hospital [Recruiting] Birmingham, United Kingdom, B15 2TH
	Addenbrookes Hospital [Recruiting] Cambridge, United Kingdom, CB2 2QQ
	University Hospital Coventry & Warwickshire NHS Trust [Recruiting] Coventry, United Kingdom, CV2 2DX
	Doncaster and Bassetlaw Hospitals NHS Foundation Trust [Recruiting] Doncaster, United Kingdom, DN2 5LT
	Centre for Genomic and Experimental Medicine [Recruiting] Edinburgh, United Kingdom, EH4 2XU
	Royal Liverpool University Hospital [Recruiting] Liverpool, United Kingdom, L7 8XP
	University College Hospital [Recruiting] London, United Kingdom, NW1 2PG
	Guy's and St Thomas' Hospital [Recruiting] London, United Kingdom, SE1 7EH
	Chelsea And Westminster Hospital [Not yet recruiting] London, United Kingdom, SW10 9NH
	Royal Gwent Hospital [Withdrawn] Newport, United Kingdom, NP20 2UB
	Norfolk and Norwich University Hospital [Withdrawn] Norwich, United Kingdom, NR4 7UY
	Hope Hospital [Recruiting] Salford, United Kingdom, M6 8HD
	Southampton University Hospitals NHS Trust [Recruiting] Southampton, United Kingdom, SO16 6YD
	Kings Mill Hospital [Recruiting] Sutton In Ashfield, United Kingdom, NG17 4JL

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