Cure8 trial brief
This trial tests standardized encapsulated fecal microbiota products as a microbiome-directed therapy for active Crohn’s disease, focusing on whether donor microbes engraft in the ileum and colon and whether that relates to symptoms or endoscopic findings.
Adult patients with active Crohn’s disease interested in microbiome therapies, clinicians monitoring emerging FMT approaches, and researchers studying microbial engraftment and therapeutic microbiota formulations.
This is a recruiting interventional Phase 2 trial (planned enrollment 120) comparing two capsule formulations: MTP-101C (double-encapsulated freeze-dried donor microbiota designed for delayed release) and MTP-101S (double-encapsulated donor microbiota formulated to disintegrate in the proximal small bowel).
The primary outcome is donor microbial engraftment measured in ileal biopsies at two months. The study includes adults with endoscopically active Crohn’s disease and requires stable maintenance therapy for most background CD treatments. The trial is being conducted at multiple U.S. centers (University of Minnesota, NYU Langone, UT Southwestern).
Eligibility and exclusion criteria are typical for microbiome transplantation studies (e.g., recent antibiotic use excluded, pregnancy excluded, significant prior bowel surgery or short-bowel concerns excluded).
This is a Phase 2 interventional trial record (recruiting) describing study design and endpoints; it does not report results. The primary endpoint is microbial engraftment measured in ileal biopsies at 2 months. Standard exclusions for FMT trials apply (recent antibiotics, certain surgeries, pregnancy, immunodeficiency).
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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