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Transfer of Feces in Ulcerative Colitis 2 (TURN2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05998213
Recruitment Status : Recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
Sponsor:
Collaborators:
University Medical Center Groningen
UMC Utrecht
Information provided by (Responsible Party):
Cyriel Y Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief Summary:

The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis.

Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas).

Donors are selected based on microbiota profile.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Ulcerative Colitis Flare Ulcerative Colitis Acute Other: Fecal microbiota transplant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Donor fecal microbiota transplant Other: Fecal microbiota transplant
Frozen FMT via duodenal tube (2 times) and enemas (4 times)
Other Name: FMT
Placebo Comparator: Autologous fecal microbiota transplant Other: Fecal microbiota transplant
Frozen FMT via duodenal tube (2 times) and enemas (4 times)
Other Name: FMT


Outcome Measures
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Primary Outcome Measures :
  1. Clinical and endoscopic remission [ Time Frame: week 8 ]

    per adapted Mayo: stool frequency subscores (SFS) ≤ 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore ≤ 1.

    The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score. A higher score reflects worse outcome.



Secondary Outcome Measures :
  1. Clinical response [ Time Frame: week 8 ]

    Adapted Mayo: decrease from baseline ≥ 2 points and ≥ 30% plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.

    The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score.


  2. Endoscopic response, evaluated by sigmoidoscopy [ Time Frame: week 8 ]
    •Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 and <70
  • Ability to give informed consent
  • Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
  • Partial mayo score of ≥ 3 and calprotectin > 250
  • Full Mayo score 5-9
  • Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy
  • Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks.
  • Stable dose of budesonide in preceding 2 weeks.
  • Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4.
  • Women need to use reliable contraceptives during participation in the study
  • Alkaline phosphatase > 1.5 x ULN in the subgroup of PSC/UC patients.

Exclusion Criteria:

  • Condition leading to profound immunosuppression

    • For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies
    • Use of systemic chemotherapy
    • Child-Pugh B liver cirrhosis
  • Anti-TNFα treatment in preceding 2 months
  • Vedolizumab treatment in preceding 2 months
  • Tofacitinib treatment in preceding 2 months
  • Ustekinumab treatment in preceding 2 months
  • Cyclosporine treatment in preceding 4 weeks
  • Use of Methotrexate in preceding 2 months
  • Prednisolone dose > 15 mg/day in preceding 2 weeks
  • Use of topical therapy in preceding 2 weeks
  • Life expectancy < 12 months
  • Difficulty with swallowing
  • Use of systemic antibiotics in preceding 4 weeks
  • Use of probiotic treatment in preceding 4 weeks
  • Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
  • Positive C. Difficile stool test
  • Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen.
  • Positive serological test for HIV

  • History of surgery:

    • presence of a pouch
    • presence of stoma
  • Known intra-abdominal fistula
  • Pregnancy or women who give breastfeeding
  • Vasopressive medication, icu stay
  • Signs of ileus, diminished passage
  • Allergy to macrogol or substituents, eg peanuts, shellfish
  • Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver
  • Crohn's disease
  • Subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998213


Contacts
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Contact: Cyriel Ponsioen, prof. +31 20 5668278 c.y.ponsioen@amsterdamumc.nl
Contact: Melanie Benard, Msc 0031645050314 m.v.benard@amsterdamumc.nl

Locations
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Netherlands
Amsterdam University Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1061BK
Contact: Melanie V. Bénard, Msc       m.v.benard@amsterdamumc.nl   
Contact: Florine Jiwa       f.h.jiwa@amsterdamumc.nl   
Principal Investigator: Rinse K. Weersma, Prof. dr.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Groningen
UMC Utrecht
More Information
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Responsible Party: Cyriel Y Ponsioen, prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT05998213    
Other Study ID Numbers: NL65069.018.18
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases