NCT05998213

Transfer of Feces in Ulcerative Colitis 2

Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Fecal microbiota transplant	Frozen FMT via duodenal tube (2 times) and enemas (4 times)

Timeline

• Start date: 2020-06-12
• Primary completion: 2025-01-10
• Completion: 2025-12-18
• First posted: 2023-08-18
• Last updated: 2026-03-20

Locations

1 site across 1 country: Netherlands