History of Changes for Study: NCT03843385

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis (FRESCO)

Latest version (submitted November 21, 2023) on ClinicalTrials.gov

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	February 14, 2019	None (earliest Version on record)
2	February 19, 2019	Outcome Measures and Study Status
3	September 8, 2021	Study Status
4	November 21, 2023	Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations, Outcome Measures, Study Design, IPDSharing, Eligibility, Arms and Interventions, Study Description and Oversight

Comparison Format:

Merged
Side-by-Side

Scroll up to access the controls

Study NCT03843385
Submitted Date: February 14, 2019 (v1)

Study Identification


Unique Protocol ID:	KS2017-114
Brief Title:	Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis (FRESCO)
Official Title:	Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis
Secondary IDs:

Study Status


Record Verification:	January 2019
Overall Status:	Not yet recruiting
Study Start:	May 2019
Primary Completion:	December 2020 [Anticipated]
Study Completion:	September 2021 [Anticipated]

First Submitted:	February 14, 2019
First Submitted that Met QC Criteria:	February 14, 2019
First Posted:	February 18, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	February 14, 2019
Last Update Posted:	February 18, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Jena University Hospital
Responsible Party:	Sponsor
Collaborators:	German Federal Ministry of Education and Research

Study Description

Brief Summary:

FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.

Detailed Description:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease with significant morbidity and mortality. Although the precise cause remains unknown, disturbances in the intestinal microbial community and changes in the crosstalk between the microbiota and the mucosal immune system have been linked to its pathogenesis. As current therapies are limited, there is a medical need for new therapies. Faecal microbiota transplantation (FMT) has been proven to be effective in managing relapsing Clostridium difficile infection (CDI) and preliminary results indicated that also the transfer of filtrates of donor stool (FMFT) drives gastrointestinal microbiota changes and eliminate symptoms in CDI patients. FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated FMT or FMFT compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active UC. The primary outcome will be clinical and endoscopic remission at week 12. This proposal aims to examine: (a) the efficacy of FMT / FMFT as a therapy for mild-moderate UC, (b) the short- and long-term safety of FMT / FMFT in patients with UC and (c) the microbial and immunologic changes that occur after FMT / FMFT, to help understand how and why it works in this group of patients. All analyses will be conducted in both intention-to-treat (primary) and per-protocol (sensitivity analyses) populations, and the differences in remission rates and relapse rates between the groups will be statistically analysed to determine the efficiency of FMT versus FMFT.

Conditions


Conditions:	Ulcerative Colitis Inflammatory Bowel Diseases
Keywords:	fecal transplantation multidonor fecal transplantation

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
	Patients will be randomized 1:1:1 to receive intensive dosing multi-donor FMFT or FMT as therapeutic strategies or saline as a placebo comparator. To achieve balanced distributions for pretreatment factors, we propose to apply stratified (stratum 1: no steroids / steroids / thiopurines / steroids and thiopurines; stratum 2: "participating centre") block randomization of variable block sizes.
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	174 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: faecal microbiota filtrate Encapsulated faecal microbiota filtrate . 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or apple juice.	Drug: encapsulated faecal microbiota filtrate Multidonor stool mixed with sterile normal saline, homogenized, filtered, centrifuged, air pressure filtered, encapsulated in hypromellose capsules and frozen. Other Names: FMFT
Active Comparator: faecal microbiota Encapsulated faecal microbiota. 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or apple juice.	Drug: encapsulated faecal microbiota Multidonor stool mixed with sterile normal saline, homogenized, filtered, encapsulated in hypromellose capsules and frozen. Other Names: FMT
Sham Comparator: Placebo Placebo: Encapsulated sterile saline. 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or apple juice.	Drug: Placebo Sterile saline encapsulated in hypromellose capsules and frozen. Other Names: Encapsulated sterile saline

Outcome Measures


Primary Outcome Measures:
1.	clinical remission [ Time Frame: 12 weeks ] The primary outcome will be clinical remission at week 12 post first transfer of FMFT or FMT, defined by Mayo score ≤ 2 without any subscore >1 and a Mayo endoscopic subscore 0-1; additionally patients unavailable at the week 12 follow-up will be included as non-responders (i.e. counted no remission).
Secondary Outcome Measures:
1.	steroid-free clinical remission [ Time Frame: 12 weeks ] steroid-free clinical remission at week 12 post first transfer of FMFT or FMT, defined by Mayo score ≤ 2 without any subscore >1 and a Mayo endoscopic subscore 0-1; additionally patients unavailable at the week 12 follow-up will be included as non-responders (i.e. counted no remission).
2.	clinical response [ Time Frame: 12 weeks ] clinical response is defined by decrease in Mayo score by 3 points, decrease in bleeding subscore by 1 as an important patient-related outcome parameter, or absolute sub-score of 0-1
3.	change in quality of life [ Time Frame: 12 weeks ] assessed by Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Prior endoscopic confirmation of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Having active disease, defined with a Mayo Score between 4-9 and Mayo endoscopic subscore >1 May be receiving the following drugs (subjects on these therapies must be willing to remain on stable doses for the noted times oral 5-ASA compounds (5-ASA) compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must be stable for first 12 weeks after randomization) Azathioprine, 6-Mercaptopurine (6-MP) or Methotrexate (MTX) provided the dose prescribed has been stable for 4 weeks prior to randomization; dose must be stable for first 12 weeks after randomization. Oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 20 mg/day or budesonide prescribed at a stable dose of ≤ 9 mg/day) provided the dose prescribed has been stable for 2 weeks prior to randomization. Ability to understand and willingness to sign informed consent document in patients whom the investigator believes can and will comply with the requirements of the protocol. Exclusion Criteria: Crohn's disease or indeterminate colitis or proctitis alone Acute abdomen or other clinical emergencies requiring emergent management (e.g. bowel obstruction, perforation and/or abscess, previous bowel surgery) Concurrent gastrointestinal infections Other causes of diarrhoea Congenital or acquired immunodeficiency, severe comorbidities (e.g. diabetes mellitus, cancer, systemic lupus, decompensated cirrhosis, recent malignancy in the last 5 years) Pregnancy Patients who are unable or unwilling to undergo colonoscopy, conscious sedation with colonoscopy Previous treatment with TNF- or integrin-antibodies Any antibiotic use within the last 3 months Participation in a clinical trial within the last 3 months Prior history of FMT Probiotic use within 30 days of start date

Contacts/Locations


Central Contact Person:	Andreas Stallmach, Prof. Telephone: +49-3641-9 Ext. 324401 Email: andreas.stallmach@med.uni-jena.de
Central Contact Backup:	Philip C Grunert, MD Telephone: +49-3641-9 Ext. 324465 Email: philip.grunert@med.uni-jena.de
Study Officials:	Andreas Stallmach, Prof. Study Director Jena University Hospital
Locations:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services