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Transfer of Feces in Ulcerative Colitis 2

NCT05998213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-03-20

No results posted yet for this study

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

Interventions

OTHER

Fecal microbiota transplant

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

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2025-01-10
Completion
2025-12-18

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998213 on ClinicalTrials.gov