Cure8 trial brief
People with Crohn's disease often ask whether food additives and artificial sweeteners affect gut microbes or disease activity. This trial directly tests whether sucralose changes the fecal microbiome in adults with Crohn's disease compared with healthy controls.
Adults with Crohn's disease (in remission), clinicians who counsel patients about diet and additives, and researchers studying diet–microbiome interactions in IBD.
This is a recruiting, interventional clinical trial at Case Western Reserve University/University Hospitals enrolling adults 18–75 with Crohn's disease in remission and healthy controls. The study has two phases: a 14-day baseline period with removal of non-nutritive sweeteners from the diet, then a 21-day sucralose exposure (2 sachets/day; ~2.5 mg/kg/day).
Participants provide stool, urine, and blood samples at specified visits for metagenomic microbiome analysis. Participation details: Planned enrollment is 40 participants. Key exclusions include recent antibiotics, active malignancy, ostomy, symptomatic strictures, recent medication changes, pregnancy/lactation, and certain surgical histories.
The primary outcome is change in the fecal microbiome measured by metagenomic analysis at baseline and after intervention. Study context: This is a short, proof-of-principle trial focused on Crohn's disease as a model; results would inform whether sucralose affects gut microbes in IBD and could guide larger or longer studies.
This is a small, short-term interventional study (planned N=40) performed in adults with Crohn's disease in remission; it measures microbiome changes but does not by itself establish clinical effects on disease activity. The protocol excludes recent antibiotic use and other factors that could confound microbiome results.
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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