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

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ClinicalTrials.gov Identifier: NCT02858557
Recruitment Status : Unknown
Verified August 2016 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.

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.


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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

Resource links provided by the National Library of Medicine


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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858557


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

Locations
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Israel
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Iris Dotan, MD Head, IBD center, Department of gastroenterology and liver diseases, Tel Aviv Sourasky Medical Center

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02858557     History of Changes
Other Study ID Numbers: 0240-16-TLV
First Posted: August 8, 2016    Key Record Dates
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:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases