NCT02858557

The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases

The Effect of the Mediterranean Diet and the Specific Carbohydrate Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Inflammatory Bowel Diseases
• Crohn's Disease
• Dietary Modification

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean diet	The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats.
BEHAVIORAL	Specific Carbohydrate Diet	The specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-08-08
• Last updated: 2016-08-08

Locations

1 site across 1 country: Israel