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

Not Applicable

• Conditions: Dietary Modification; Inflammatory Bowel Diseases; Crohn's Disease
• Interventions: Behavioral: Mediterranean diet; Behavioral: Specific Carbohydrate Diet

• Registration Number: NCT02858557
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2016-07-28
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-08
• Last Update Posted: 2016-08-08
• Study Start: 2016-09
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients aged 18-75;
• Able and willing to sign an informed consent;
• Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.

Exclusion Criteria

• Patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, significant comorbidity that precludes the patient from participating according to the physicians' judgment, non-Hebrew readers, pregnant and lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Specific Carbohydrate Diet	Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet
Group A	Mediterranean diet	Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet
Group A	Specific Carbohydrate Diet	Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet
Group B	Mediterranean diet	Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet

Primary Outcome Measures

Name	Time	Method
Microbial diversity	7 days	Shannon α-diversity index

Secondary Outcome Measures

Name	Time	Method
Quality of life	7 days	Inflammatory bowel diseases questionnaire (IBDQ)
Clinical score	7 days	Pouchitis Disease Activity Index (PDAI)
fecal calprotectin	7 days	Inflammatory marker
Microbial composition	7 days	Change in the abundance of microbial taxa
C-reactive protein (CRP)	7 days	Inflammatory marker

Trial Locations

Locations (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel