Cure8 trial brief
If sodium intake influences gut proteolytic activity, microbiota and inflammation, the findings could help tailor dietary guidance and personalized nutrition strategies for people with Crohn’s disease.
Adult patients with Crohn’s disease, dietitians and clinicians managing IBD, and researchers interested in diet–microbiome–inflammation links.
This is a longitudinal exploratory registry enrolling 300 adults with Crohn’s disease (Phase 1) with annual follow-up for two years to track dietary sodium, stool and blood biomarkers, urine sodium, microbiome profiles, fecal proteolytic activity, fecal calprotectin and clinical disease activity.
A nested Phase 2 intervention-like sub-study will select 80 participants (40 high-sodium, 40 low-sodium) for intensive short-term sampling over two weeks including colonoscopy with biopsies at week 2 and detailed dietary tracking. Study design notes The record describes an observational, recruiting study based at McMaster University.
Key eligibility excludes recent antibiotics/probiotics and pregnancy. Outcomes focus on correlating sodium intake with proteolytic activity, mucosal measures and disease activity rather than testing a specific drug or treatment.
This is an observational study/registry with a short intensive sub-study; it will identify associations rather than prove causation. The record is a trial registration (recruiting) rather than a peer-reviewed result, so it describes planned data collection and outcomes rather than 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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