Clincosm LogoSign in Get a demo

TURN2: Transfer of Feces in Ulcerative Colitis 2

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05998213
Collaborator
University Medical Center Groningen (Other), UMC Utrecht (Other)
76
Enrollment
1
Location
2
Arms
83.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Fecal microbiota transplant
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 5, 2018
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Donor fecal microbiota transplant

Other: Fecal microbiota transplant
Frozen FMT via duodenal tube (2 times) and enemas (4 times)
Other Names:
  • FMT

    		•
    Placebo Comparator: Autologous fecal microbiota transplant

    Other: Fecal microbiota transplant
    Frozen FMT via duodenal tube (2 times) and enemas (4 times)
    Other Names:
  • FMT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical and endoscopic remission [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 [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 [week 8]

      •Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Amsterdam University Medical Center Amsterdam Noord-Holland Netherlands 1061BK

    Sponsors and Collaborators

    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    • University Medical Center Groningen
    • UMC Utrecht

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer

    Study Results

    No Results Posted as of Aug 18, 2023