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FMT-SCLER randomized sham-controlled trial in primary sclerosing cholangitis
2023-505469-95-00Phase 3Authorised
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Start
- Dec 2025
- 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, double-blind trial of allogeneic pooled fecal microbiota in Primary Sclerosing Cholangitis (PSC) (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Biochemical success at week 48. Planned start Dec 2025; status: authorised.
02
Drugs
allogeneic pooled fecal microbiota
03
Conditions
Primary Sclerosing Cholangitis (PSC)
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