Cure8 trial brief
This trial explores a novel, local intestinal buffering strategy (amorphous calcium carbonate) as a potential anti-inflammatory approach for moderate-to-severe Crohn's disease and reports clinical, endoscopic, biomarker, and safety endpoints—information patients and clinicians may find relevant when watching emerging non-biologic therapies.
Adults with moderate-to-severe Crohn's disease, clinicians treating Crohn's disease, clinical researchers in IBD drug development, and patients interested in non-biologic, gut-targeted therapies.
This trial tests a non-biologic, local gut‑targeted approach: ACC in an enteric formulation meant to neutralize intestinal acidity as a way to reduce inflammation.
Participants received pH Gastrilex™ (2 capsules four times daily; 1,600 mg elemental calcium/day) versus matching placebo for 12 weeks alongside best available treatment, with crossover to active treatment after Week 12 and an open‑label extension offered through Week 72.
The study measured clinical disease activity (CDAI) at 12 and 24 weeks, endoscopic evaluation by colonoscopy, CRP and fecal calprotectin, quality-of-life scores, and safety/tolerability. Planned enrollment was small (23) and the registry lists the study as completed at a single center in Israel.
Practical points: the formulation delivers elemental calcium and includes exclusion criteria for hypercalcemia/hypercalciuria and recent biologic or steroid changes; safety monitoring included labs and adverse-event reporting.
This entry is a clinicaltrials.gov trial record (Phase 2, single-center, planned N=23) and should be interpreted as a trial registry description of design, interventions, and planned outcomes rather than as a report of published results.
The small planned sample size and single-center design limit generalizability; the record lists exclusion criteria related to hypercalcemia and recent biologic or steroid use.
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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