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
Inclusion Criteria12
- 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 Criteria22
- 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)
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)
View Full Details on ClinicalTrials.gov
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NCT03843385
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