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RECRUITING
NCT03843385
PHASE3

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Sponsor: Andreas Stallmach

View on ClinicalTrials.gov

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.

Official title: Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2023-01-31

Completion Date

2027-04

Last Updated

2026-02-13

Healthy Volunteers

No

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.

Locations (20)

Jena University Hospital

Jena, Thuringia, Germany

Sozialstiftung Bamberg

Bamberg, Germany

Charité Berlin

Berlin, Germany

DRK Kliniken Berlin Westend

Berlin, Germany

Havelhöhe

Berlin, Germany

Krankenhaus Waldfriede

Berlin, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

FAU Universität Erlangen-Nürnberg

Erlangen, Germany

Agaplesion Markus Krankenhaus

Frankfurt, Germany

Universitätsklinik Freiburg

Freiburg im Breisgau, Germany

Klinikum Fulda

Fulda, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Schleswig Holstein

Kiel, Germany

Gesellschaft Klinische Studien Leipzig

Leipzig, Germany

St. Marien- und St. Annastiftskrankenhaus

Ludwigshafen, Germany

Städtisches Klinikum Lüneburg

Lüneburg, Germany

Otto-von-Guericke-Universität - Medizinische Fakultät

Magdeburg, Germany

LMU Klinikum München - Campus Großhadern

München, Germany

Universitätsklinikum Ulm

Ulm, Germany