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Multicenter, prospective, double-blind, randomized, three-armed, placebo-controlled study of long-term therapeutic transfer of encapsulated stool microbiome for the treatment of active ulcerative colitis
EU CTIS ID: 2024-517132-22-00
What this study is testing
clinical efficacy of long-term transplantation of capsules with faecal microbiota and faecal microbiota filtrate
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age between 18 and 75 years
- • written consent
- • prior endoscopic confirmation of colitis ulcerosa (first diagnosis of at least 6 months, active disease: mayo score between 4-10 points at screening, documented endoscopic minimum disease extent of 15 cm from the anal verge (mayo endoskopic subscore >1)
- • Failure of conventional therapy or treatment with biologicals and/or small molecules
- • previous medical therapy: -oral 5-ASA compounds (5-ASA) (stable dose for 4 weeks before randomisation) OR -Azathioprine, 6-MP or MTX (stable dose for 8 weeks before randomisation) OR -oral steroid therapy: (prednisone (≤ 20 mg/day) or budesonide (≤ 9 mg/day)) (stable dose for 2 weeks before randomisation) OR -topical therapy (foams, clysms) with mesalazine or budesonide (stable dose for 2 weeks before randomisation)
- • previous vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology
You likely can't join if
- • Crohn´s disease, indeterminate colitis or ulcerative proctitis (< 15 cm ab ano)
- • lack of immunity to SARS-CoV-2
- • Previous treatment with TNF-, IL12/IL23-, IL23- or integrin-antibodies (8 weeks before randomisation)
- • Treatment with calcineurin inhibitors (4 weeks before randomization)
- • Treatment with JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) (4 weeks before randomization)
- • Treatment with S1P receptor modulator (e. g. ozanimod, etrasimod) (4 weeks before randomization)
See the full eligibility criteria
Who can join
- • Age between 18 and 75 years
- • written consent
- • prior endoscopic confirmation of colitis ulcerosa (first diagnosis of at least 6 months, active disease: mayo score between 4-10 points at screening, documented endoscopic minimum disease extent of 15 cm from the anal verge (mayo endoskopic subscore >1)
- • Failure of conventional therapy or treatment with biologicals and/or small molecules
- • previous medical therapy: -oral 5-ASA compounds (5-ASA) (stable dose for 4 weeks before randomisation) OR -Azathioprine, 6-MP or MTX (stable dose for 8 weeks before randomisation) OR -oral steroid therapy: (prednisone (≤ 20 mg/day) or budesonide (≤ 9 mg/day)) (stable dose for 2 weeks before randomisation) OR -topical therapy (foams, clysms) with mesalazine or budesonide (stable dose for 2 weeks before randomisation)
- • previous vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology
- • Ability to understand study procedures and willingness to meet requirements associated with participation (e. g. endoscopy, intake antibiotics)
- • potentially childbearing patient: negative pregnancy test and use of a highly effective contraceptive method
What rules you out
- • Crohn´s disease, indeterminate colitis or ulcerative proctitis (< 15 cm ab ano)
- • lack of immunity to SARS-CoV-2
- • Previous treatment with TNF-, IL12/IL23-, IL23- or integrin-antibodies (8 weeks before randomisation)
- • Treatment with calcineurin inhibitors (4 weeks before randomization)
- • Treatment with JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) (4 weeks before randomization)
- • Treatment with S1P receptor modulator (e. g. ozanimod, etrasimod) (4 weeks before randomization)
- • Systemic antibiotic treatment (8 weeks before randomization)
- • Known intolerance to metronidazole or vancomycin
- • Participation in a clinical trial (3 months before randomization)
- • Previous FMT or FMFT, previous participation in this study (screening allowed)
- • Use of probiotics in tablet, capsule, or powder form, or appropriate drinking yogurts (or similar) (2 weeks before randomization)
- • Acute abdomen or other clinical emergencies (toxic megacolon, fulminant gastrointestinal hemorrhage, ileus, perforation, etc.)
- • Failure to ensure frozen storage of investigational products: no possibility to store capsules at ≤ -10°C, planned longer absence (12 weeks after randomization)
- • 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)
- • Previous operations on the colon: colectomy, partial colon resections
- • current gastrointestinal infections (e. g. Clostridium difficile infection, CMV infection) until randomisation
- • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.