Transfer of Feces in Ulcerative Colitis 2

NCT05998213 | Completed Phase 2 DMC

• 1 other identifier: NL65069.018.18
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Ulcerative Colitis Flare; Ulcerative Colitis Acute

Outcome Measures

Primary Outcomes (1)

• Clinical and endoscopic remission

  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.

  week 8

Secondary Outcomes (13)

• Clinical response

  week 8

• Clinical improvement

  week 8

• Clinical remission

  week 8

• Complete remission

  week 8

• Sustained steroid-free remission

  week 52

Study Arms (2)

Donor fecal microbiota transplant

EXPERIMENTAL

Other: Fecal microbiota transplant

Autologous fecal microbiota transplant

PLACEBO COMPARATOR

Other: Fecal microbiota transplant

Interventions

Fecal microbiota transplant OTHER

Frozen FMT via duodenal tube (2 times) and enemas (4 times)

Also known as: FMT

Autologous fecal microbiota transplant; Donor fecal microbiota transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, North Holland, 1061BK, Netherlands

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 18, 2023
• Study Start: June 12, 2020
• Primary Completion: January 10, 2025
• Study Completion: December 18, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)