The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
NCT ID: NCT02858557
Last Updated: 2016-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2016-09-30
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Group A
Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet
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.
Group B
Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Iris Dotan, MD
Role: PRINCIPAL_INVESTIGATOR
Head, IBD center, Department of gastroenterology and liver diseases, Tel Aviv Sourasky Medical Center
Locations
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Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Other Identifiers
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0240-16-TLV
Identifier Type: -
Identifier Source: org_study_id
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