Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Launched by ANDREAS STALLMACH · Feb 14, 2019

Keywords

ClinConnect Summary

This clinical trial, called FRESCO, is investigating a new treatment for people with active ulcerative colitis, a condition that causes inflammation in the digestive tract. The study will compare the effects of frozen oral capsules containing stool filtrate from multiple donors against a placebo (a treatment that has no active ingredients) to see if it can help improve symptoms and safely treat the disease. The trial is looking for adults aged 18 to 75 who have been diagnosed with ulcerative colitis for at least six months and have tried standard treatments without success.

Participants in this study can expect to be randomly assigned to receive either the active treatment or the placebo, and their progress will be monitored over time. To join, individuals must have active disease symptoms and meet certain health criteria, such as having tried specific medications for their condition. It’s important to note that participants will need to be able to understand the study and provide informed consent. The trial is currently recruiting participants, and it offers a potential new option for those struggling with ulcerative colitis.

Gender

ALL

Eligibility 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)