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Clinical Trials in Germany / NCT03843385
Active, not recruiting Phase 3

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

NCT03843385 · tracked via the Priya Life Science Germany tracker
Sponsor
Andreas Stallmach
Phase
Phase 3
Started
2023-01-31
Last updated
2026-08-10

Condition(s) studied

Ulcerative ColitisInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

encapsulated faecal microbiota filtrateencapsulated faecal microbiotaPlacebo

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

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

Placebo: Sterile saline encapsulated in hypromellose capsules and frozen.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18 and 75 years * Prior endoscopic confirmation of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. * Having active disease, defined with a Mayo Score between 4-10 and Mayo endoscopic subscore \>1 * Failure of conventional therapy or treatment with biologicals and / or small molecules. * previous medical therapy: * oral 5-ASA compounds (5-ASA); stable dosing for 4 weeks before randomization; * Azathioprine, 6-Mercaptopurine (6-MP) or Methotrexate (MTX); stable dosing for 8 weeks before randomization; * Oral corticosteroid therapy (prednisone ≤ 20 mg/day or budesonide ≤ 9 mg/day); stable dosing for 2 weeks before randomization; * Topical therapy (foams, clysms) with mesalazine or budesonide: stable dosing for 2 weeks before randomization. * previous vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology * Ability to understand and willingness to sign informed consent document in patients whom the investigator believes can and will comply with the requirements of the protocol. * Potentially childbearing patient: negative pregnancy test and use of a highly effective contraceptive method Exclusion Criteria: * Crohn's disease or indeterminate colitis or proctitis ulcerosa alone * Acute abdomen or other clinical emergencies (e.g. toxic megacolon, fulminant gastrointestinal hemorrhage, ileus, perforation, etc.) * Previous operations on the colon: colectomy, partial colon resections * current gastrointestinal infections * Congenital or acquired immunodeficiency * severe comorbidity (e.g. insulin-dependent diabetes mellitus, decompensated liver cirrhosis, primary sclerosing cholangitis, renal impairment \> grade 2) * diagnosis of a malignoma in the last 3 years * refusal of endoscopies with video documentation * No specific therapy for ulcerative colitis to date * Lack of immunity to SARS-CoV-2 * Previous treatment with TNF-, IL12/IL23-, IL23- or integrin-antibodies within the last 8 weeks before randomisation * Treatment with calcineurin inhibitors within the last 4 weeks before randomization * Treatment with JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) within the last 4 weeks prior to randomization * Treatment with S1P receptor modulators (e.g. ozanimod, etrasimod) within the last 4 weeks before randomization * Systemic antibiotic treatment within the last 8 weeks prior to randomization. * Known intolerance of metronidazole or vancomycin * Previous FMT or FMFT, previous participation in this study (screening allowed) * Participation in a clinical trial within the last 3 months * Use of probiotics in tablet, capsule, or powder form, or appropriate drinking yogurts (or similar) within 2 weeks prior to randomization * Failure to ensure frozen storage of investigational products * Addictive or other medical conditions or circumstances that do not allow the subject to appreciate the nature, significance, scope, and possible consequences of the clinical trial * Indications that the patient would be unlikely to comply with the protocol (e.g., unwillingness to cooperate - compliance questionable)

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Jena University Hospital Jena Thuringia
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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03843385 on ClinicalTrials.gov ↗ ← All trials in Germany