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NCT03843385 · ClinicalTrials.gov record · last posted 2026-08-10

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Study acronym: FRESCO
StatusActive, Not Recruiting
PhasePhase 3
Started2023-01-31
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-11
Enrollment closed, study ongoing
2026-08-11
Enrollment reduced: 129 → 84 participants
2026-08-11
Primary completion pushed: 2026-07 → 2026-08
Trial Details
NCT Number NCT03843385
Lead Sponsor Andreas Stallmach
Collaborators: German Federal Ministry of Education and Research
Conditions Ulcerative Colitis, Inflammatory Bowel Diseases
Enrollment 84 participants
Start Date 2023-01-31
Primary Completion 2026-08 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-10