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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02858557
Other study ID # 0240-16-TLV
Secondary ID
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


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
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