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Trial intelligence / Profile preview
Encapsulated Stool Microbiome Transfer in Active Ulcerative Colitis
2024-517132-22-00Phase 3Authorised
- Sponsor
- Friedrich Schiller University Jena
- Start
- Nov 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, double-blind trial in autoimmune colitis comparing Fecal microbiome (FM) capsules, Fecal microbiome filtrate (FMF) capsules and Placebo capsules (3 arms). Primary endpoint: Clinical remission at week 12. Planned start Nov 2024; status: authorised.
02
Drugs
fecal microbiome transplantfecal microbiome filtrate
03
Conditions
autoimmune colitis
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Study design, results and competitive context are available in the Gosset platform where reported.
Competitive context
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