Cure8 trial brief
This trial tests an oral live biotherapeutic (MH002) aimed at restoring a healthier gut microbiome in people with mild-to-moderate ulcerative colitis. If effective and safe, it would offer a non-immunosuppressive, microbiome-based treatment option.
Adults with mild-to-moderate ulcerative colitis (and caregivers), clinicians and researchers interested in microbiome therapeutics, and people considering clinical trial participation for UC.
This is a recruiting Phase 2 interventional trial (planned N=204) comparing two doses of MH002 versus placebo with primary endpoint assessed by Mayo Endoscopic Subscore at 12 weeks. MH002 is described as a microbiome-based live biotherapeutic product administered once daily by capsule; prior pilot data in 45 UC patients are referenced in the record.
The trial excludes patients who previously received advanced UC biologic or small-molecule therapies (anti-TNF, anti-integrin, anti-IL-12/23/IL-23 agents, JAK inhibitors, S1P modulators) and those with recent antibiotic, probiotic, prebiotic use or prior FMT within 52 weeks. Standard safety and lab exclusion criteria apply.
If you are considering study participation, discuss eligibility, potential benefits, and risks with the study team; this record describes the study protocol but does not report results.
This is a Phase 2 study protocol and is recruiting; the record does not present efficacy results. The trial excludes patients who have used many advanced UC treatments and recent microbiome-modifying therapies (antibiotics, probiotics, FMT), which may affect who is eligible.
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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