Cure8 trial brief
This trial is testing whether a rectally delivered probiotic can change the gut microbiome and promote mucosal healing in people with mild-to-moderate ulcerative colitis (and includes some Crohn's patients). If successful, it could point to microbiome-focused treatments delivered directly to the diseased mucosa.
Adults with mild-to-moderate ulcerative colitis, IBD clinicians and researchers studying microbiome or live biotherapeutics, and patients considering participation in clinical trials of probiotic/LBP interventions.
This ClinicalTrials.gov record describes an interventional study testing rectal administration of a specific probiotic (a next-generation/live biotherapeutic-type approach is discussed) in adults with mild-to-moderate ulcerative colitis and Crohn's disease.
Planned enrollment is 20, primary outcome is rectal mucosal healing assessed over 1 year, and the protocol includes collection of additional rectal biopsies to evaluate effects on gut microbiota. Eligibility allows stable 5-ASA and low-dose corticosteroids but excludes recent biologics, multiple prior biologic failures, and other immunosuppressants.
The record is a trial registration (recruiting) rather than trial results.
This entry is a trial registration (recruiting) and does not report results. The intervention is described as a 'specific probiotic' with rectal administration and includes biopsy-based microbiome evaluation; safety, efficacy, and long-term effects are not available from this record.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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