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
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.
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
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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