Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

• Register: ClinicalTrials.gov
• Last refreshed on: 30 September 2024
• Main ID: NCT03843385
• Date of registration: 14/02/2019
• Prospective Registration: Yes
• Primary sponsor: Andreas Stallmach
• Public title: Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis FRESCO
• Scientific title: Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis
• Date of first enrolment: January 31, 2023
• Target sample size: 174
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03843385
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Andreas Stallmach, Prof.
• Affiliation: Jena University Hospital

• Name: Andreas Stallmach, Prof.

Key inclusion & exclusion criteria

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)


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Inflammatory Bowel Diseases

Intervention(s)

Drug: encapsulated faecal microbiota

Drug: encapsulated faecal microbiota filtrate

Drug: Placebo

Primary Outcome(s)

clinical remission [Time Frame: 12 weeks]

Secondary Outcome(s)

change in quality of life [Time Frame: 52 weeks]

MAYO Total Score [Time Frame: 52 weeks]

steroid-free clinical remission [Time Frame: 12 weeks]

endoscopic remission [Time Frame: 12 weeks]

microbiome analysis [Time Frame: 52 weeks]

clinical response [Time Frame: 12 weeks]

Histological mucosal inflammation - Nancy index [Time Frame: 12 weeks]

mucosal inflammation - measured through fecal calprotectin [Time Frame: 52 weeks]

Safety - adverse events and severe adverse events [Time Frame: 52 weeks]

virome analysis [Time Frame: 52 weeks]

Secondary ID(s)

KS2017-114

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Federal Ministry of Education and Research