Crohn's Disease Clinical Trial
Official title:
The Effect of the Mediterranean Diet and the Specific Carbohydrate Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.
Increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory
bowel diseases. One possible mechanism for the effect of diet on intestinal inflammation is
modification of the gut microbial composition. However, the relationship between diet, the
microbiome and intestinal inflammation is still vague.
The investigators plan to perform a crossover clinical trial. Seventy ulcerative colitis
patients post restorative proctocolectomy (pouch) will be randomly allocated into two
short-term (one week) dietary interventions, the Mediterranean diet and the specific
carbohydrate diet, to assess which diet has the required influence (i.e. increased
diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the
gut microbiome of each participant. Based on this assessment, each participant will be
treated by a personally-tailored diet for up to one year, during which microbial
composition, clinical parameters, and quality of life will be assessed.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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