Cure8 trial brief
This trial is testing a donor-derived oral microbiota therapy (MGT-006) for ulcerative colitis and will look first at safety and whether the donor microbes establish in the gut — data that could inform future development of microbiome-based treatments.
Adults with ulcerative colitis, clinicians caring for IBD patients, and researchers interested in microbiome therapeutics and fecal-derived biotherapies.
The study is randomized and open-label for the Phase 1b portion and plans to compare MGT-006 given without antibiotic pretreatment versus MGT-006 after two different 5-day antibiotic pretreatment strategies (oral vancomycin or an AMF combination).
Participants take MGT-006 for eight weeks with a four-week follow-up; progression to Phase 2a (dose exploration) depends on safety and engraftment results from Phase 1b.
The trial is exploratory and not powered for confirmatory efficacy testing; endpoints focus on safety, tolerability, microbiome engraftment, and exploratory measures of symptoms and inflammation (including endoscopic assessments performed centrally). The protocol allows dose adjustments and specifies independent safety board review.
This is an early-stage, exploratory trial (Phase 1b/2a) focused on safety and engraftment; it is not intended to provide definitive evidence of clinical benefit. The Phase 2a design depends on Phase 1b findings and will be specified in an amended protocol.
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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