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Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

NCT03843385 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-02-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

encapsulated faecal microbiota filtrate

Multidonor stool mixed with sterile normal saline, homogenized, filtered, centrifuged, air pressure filtered, encapsulated in hypromellose capsules and frozen.

DRUG

encapsulated faecal microbiota

Multidonor stool mixed with sterile normal saline, homogenized, filtered, encapsulated in hypromellose capsules and frozen.

DRUG

Placebo

Sterile saline encapsulated in hypromellose capsules and frozen.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Andreas Stallmach

    lead OTHER

Principal Investigators

  • Andreas Stallmach, Prof. · Jena University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2026-07-31
Completion
2027-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843385 on ClinicalTrials.gov