Status:
RECRUITING
Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis
Lead Sponsor:
Andreas Stallmach
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Ulcerative Colitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease with significant morbidity and mortality. Although the precise cause remains unknown, disturbances in the intestinal microbial community...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03843385
Start Date
January 31 2023
End Date
July 1 2027
Last Update
September 17 2025
Active Locations (15)
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1
Jena University Hospital
Jena, Thuringia, Germany
2
Sozialstiftung Bamberg
Bamberg, Germany
3
Charité Berlin
Berlin, Germany
4
DRK Kliniken Berlin Westend
Berlin, Germany