RecruitingPhase 3NCT03843385

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

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


Sponsor

Andreas Stallmach

Enrollment

129 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether transplanting frozen, filtered stool from healthy donors (a fecal microbiota transplant, or FMT) delivered during a colonoscopy can help put ulcerative colitis into remission in patients whose disease has not responded to standard medications. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with ulcerative colitis (UC) confirmed by colonoscopy at least 6 months ago, affecting at least 15 cm of the colon - Your disease is currently active (moderate flare as measured by the Mayo Score) - Your UC has not responded well to standard treatments (such as 5-ASA, steroids, immunosuppressants, or biologic drugs) - You have been vaccinated against COVID-19 or have had a prior COVID-19 infection - You are on a stable dose of any current UC medications **You may NOT be eligible if...** - Your disease is very severe or involves complications that would make colonoscopy unsafe - You are pregnant or breastfeeding - You have had a recent serious infection or require immune-suppressing treatment - You have not met the minimum activity threshold for current disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGencapsulated faecal microbiota filtrate

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

DRUGencapsulated faecal microbiota

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

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT03843385


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