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REBALANCE-UC: Fecal Microbiota Transplantation in Ulcerative Colitis
2024-511863-27-01Phase 3Authorised
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Start
- Dec 2024
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, single-blind trial in autoimmune colitis comparing Fecal microbiota transplantation enema with Sham placebo enema (2 arms). Primary endpoint: Steroid-free clinical and endoscopic remission at week 12. Planned start Dec 2024; status: authorised.
02
Drugs
allogeneic fecal microbiota
03
Conditions
autoimmune colitis
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