Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Recruiting Phase 3 Interventional Study
Ulcerative Colitis Inflammatory Bowel Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
129 (estimated)
Sponsor
Andreas Stallmach · Other
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About This Trial

FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age between 18 and 75 years * Prior endoscopic confirmation of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. * Having active disease, defined with a Mayo Score between 4-10 and Mayo endoscopic subscore \>1 * Failure of conventional the…
Contacts

Andreas Stallmach, Prof.

+4936419324401

andreas.stallmach@med.uni-jena.de

CONTACT

Kathleen Lange, MD

+4936419324641

Kathleen.Lange@med.uni-jena.de

CONTACT