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

• ClinicalTrials.gov Identifier: NCT02858557
• Recruitment Status: Unknown
• First Posted: August 8, 2016
• Last Update Posted: August 8, 2016
• Sponsor: Tel-Aviv Sourasky Medical Center
• Information provided by (Responsible Party): Tel-Aviv Sourasky Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases; Crohn's Disease; Dietary Modification	Behavioral: Mediterranean diet; Behavioral: Specific Carbohydrate Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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
• Study Start Date: September 2016
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A; Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet	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.
Experimental: Group B; Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet	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.

Outcome Measures

Primary Outcome Measures :

1. Microbial diversity [ Time Frame: 7 days ]
   Shannon α-diversity index

Secondary Outcome Measures :

1. Clinical score [ Time Frame: 7 days ]
   Pouchitis Disease Activity Index (PDAI)
2. C-reactive protein (CRP) [ Time Frame: 7 days ]
   Inflammatory marker
3. fecal calprotectin [ Time Frame: 7 days ]
   Inflammatory marker
4. Quality of life [ Time Frame: 7 days ]
   Inflammatory bowel diseases questionnaire (IBDQ)
5. Microbial composition [ Time Frame: 7 days ]
   Change in the abundance of microbial taxa

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Lihi Godny, B.Sc; +9723947305; lihig@tlvmc.gov.il

Locations

Israel

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

• Principal Investigator: Iris Dotan, MD; Head, IBD center, Department of gastroenterology and liver diseases, Tel Aviv Sourasky Medical Center

More Information

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT02858557
• Other Study ID Numbers: 0240-16-TLV
• First Posted: August 8, 2016
• Last Update Posted: August 8, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases