Cure8 trial brief
This early-phase trial explores a novel, targeted bacteriophage treatment for pouchitis linked to an Aeromonas-associated pathogen (MTB). For people with pouchitis after IPAA, a safe, effective phage therapy could provide a non-antibiotic option tailored to a specific microbial driver.
Patients with pouchitis after IPAA, clinicians managing pouch disorders, researchers in bacteriophage therapy and microbiome-targeted treatments
This is a single-center, single-arm early-phase (Early Phase 1) interventional study enrolling about 12 adults with pouchitis who test positive for MTB bacteria or aerolysin.
Participants will take one daily oral MTB-targeted phage dose for 14 days and be followed through Week 34 with symptom questionnaires (mPDAI), stool testing for phage and bacterial markers, and pouch endoscopy at baseline, Week 14 and Week 34. The trial uses each participant as their own control (no external control arm).
The study’s main goals are to measure change in mPDAI-defined pouchitis activity at Week 14 and to assess safety and tolerability. The registry lists standard exclusion criteria (recent antibiotics, pregnancy, other severe illnesses) and is not yet recruiting.
Early-phase, single-arm design with ~12 participants; primary aims are safety and proof-of-concept (mPDAI change). MTB is described by the investigators as a newly identified enteropathogen—its role and detection will need independent validation. Results from this study would be preliminary.
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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