Multicenter, prospective, double-blind, randomized, three-armed, placebo-controlled study of long-term therapeutic transfer of encapsulated stool microbiome for the treatment of active ulcerative colitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517132-22-00

Acronym

FRESCO

Enrollment

129

Registered

2024-11-08

Start date

2023-01-26

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

active ulcerative colitis

Brief summary

clinical remission at week 12 post transfer defined by Mayo score ≤ 2 and any subcore ≤ 1, missing values to week 12 are considered as no remission

Detailed description

- steroid-free clinical remission, - Mayo score, - endoscopic remission, - clinical response, - mucosal infammation (fecal calprotectin), - histological mucosal inflammation (Nancy index), - quality of life, - microbiome and virome analysis, - safety

Interventions

DRUGFecal Microbiome Filtrate (FMF)

DRUGVANCOMYCIN

DRUGPlacebo

DRUGunauthorised capsule

DRUGhard for oral use

DRUGMETRONIDAZOLE

DRUGFecal microbiome (FM)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
clinical remission at week 12 post transfer defined by Mayo score ≤ 2 and any subcore ≤ 1, missing values to week 12 are considered as no remission	—

Secondary

Measure	Time frame
- steroid-free clinical remission, - Mayo score, - endoscopic remission, - clinical response, - mucosal infammation (fecal calprotectin), - histological mucosal inflammation (Nancy index), - quality of life, - microbiome and virome analysis, - safety	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026