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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02858557
• Other study ID #: 0240-16-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: July 28, 2016
• Last updated: August 5, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: August 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Lihi Godny, B.Sc
• Phone: +9723947305
• Email: lihig[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mediterranean diet
The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats.
• 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.

Locations

Country	Name	City	State
Israel	Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial diversity	Shannon a-diversity index	7 days	No
Secondary	Clinical score	Pouchitis Disease Activity Index (PDAI)	7 days	No
Secondary	C-reactive protein (CRP)	Inflammatory marker	7 days	No
Secondary	fecal calprotectin	Inflammatory marker	7 days	No
Secondary	Quality of life	Inflammatory bowel diseases questionnaire (IBDQ)	7 days	No
Secondary	Microbial composition	Change in the abundance of microbial taxa	7 days	No