ClinicalTrials.gov
Cure8 trial brief
Whey Protein Milk-Derived Exosomes
Research and clinical trials
Biomarkers
Colonoscopy
Fecal calprotectin
Rectal Bleeding
Abdominal Pain
Clinical Trial Phase 1
Adult patients
Why This Matters
The trial tests a naturally derived oral supplement (WPMDE2) in patients with ulcerative colitis, measuring symptoms, inflammatory markers, and quality of life—outcomes that matter to people living with IBD. Early-phase safety data and biomarker changes could inform whether larger controlled trials are warranted.
Who Should Pay Attention
Adult patients with ulcerative colitis (mild to severe), caregivers, gastroenterologists and IBD clinicians, and researchers interested in microbiome/exosome-based therapies or nutraceutical adjuncts.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment31 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This is an open-label, uncontrolled Phase 1B study (100 participants) primarily designed to evaluate safety and tolerability of two oral dose levels of WPMDE2 given twice daily for 8 weeks, with a 2-week follow-up.
Secondary and exploratory outcomes include changes in disease activity scores, fecal calprotectin, quality-of-life (IBDQ-32), and optional endoscopic assessment in a subset of participants.
The trial allows participants to continue their usual UC treatments while taking the supplement, and endoscopy at end-of-treatment is optional (up to 15 subjects), so not all participants will have mucosal-healing data.
The registry notes prior Phase 1 safety work in healthy volunteers but this study is uncontrolled, so any efficacy signals would be preliminary and hypothesis-generating.
Keep In Mind
Open-label, uncontrolled Phase 1B studies primarily assess safety and provide preliminary signals; they do not replace randomized controlled trials for determining efficacy. Endoscopic endpoints are optional for most participants, which may limit mucosal-healing assessments.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorExosomm Ltd.
Trial IDNCT06755021
Study typeInterventional
Trial phaseNA
Enrollment31 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 16, 2026, 12:00 AM
Content availableTrial registry record
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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