Cure8 trial brief
Dietary therapies are commonly used by people with IBD; this trial tests how two specific diets affect symptoms and the gut microbiome and collects biopsies to study gene-expression and microbial changes, which could inform future dietary recommendations or biomarker research.
Adults with Crohn's disease or ulcerative colitis, dietitians and gastroenterologists, researchers studying the microbiome or dietary interventions in IBD, and patients considering enteral nutrition or the Specific Carbohydrate Diet.
This was a single-center, open-label interventional study at Massachusetts General Hospital. Eligible patients with endoscopically confirmed active disease chose one of two diet arms (partial elemental diet providing ~50% of calories plus low-residue diet, or SCD meeting full caloric needs) and received dietitian guidance.
Colonoscopy and biopsies were performed as part of routine care to confirm activity and collect samples for microbiome and gene-expression analysis. The protocol included five study visits over the 6-week dietary period and planned follow-up for 6 weeks after resuming a normal diet.
Primary outcome was clinical remission at week 6 (Harvey-Bradshaw Index or SCCAI thresholds). The record lists common IBD-related exclusions (recent antibiotics, recent surgery, active infection, pregnancy, celiac disease, presence of an ostomy or J-pouch, among others).
This ClinicalTrials.gov record describes study design and planned measurements but does not present outcomes. The trial was completed according to the registry entry; look for peer-reviewed publication(s) or results posted on the registry for efficacy and safety data.
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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