Cure8 trial brief
The trial tests two low-cost adjuncts — a Lactobacillus probiotic and a multi–trace-element supplement — added to biologic-based standard care to see if they help maintain remission in ulcerative colitis. If effective, these could offer accessible options to improve disease control.
Adults with ulcerative colitis (particularly those receiving biologics), gastroenterologists, IBD researchers, and patients interested in probiotics or micronutrient supplements.
The study will randomize patients into three open-label arms: (1) Lactobacillus acidophilus 20 billion CFU daily plus standard care, (2) a trace element tablet (Vitayami®) twice daily plus standard care, or (3) standard care alone. All groups receive routine biologic therapy per hospital protocol (example given: infliximab 5 mg/kg).
The primary outcome is reduction in Mayo score (IBD activity index) by at least 50% from baseline; mucosal healing on colonoscopy is a secondary outcome. The trial is registered as an interventional Phase 4 study and is actively recruiting at the National Hepatology & Tropical Medicine Research Institute in Cairo.
This is a registered Phase 4 interventional trial (recruiting) describing planned interventions and outcomes; it does not present results. The study is open-label and single-center, which are important design features when interpreting future findings.
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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