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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02302703 |
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Date of registration:
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25/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Low FODMAP (Fermentable Oligo-,di-,Mono-saccharides and Polyols) Versus Gluten-free Diet in Pediatric IBS Patients; a Cross-over Randomized Trial.
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Scientific title:
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Low FODMAP (Fermentable Oligo-,di-,Mono-saccharides and Polyols) Versus Gluten-free Diet in Pediatric IBS Patients; a Cross-over Randomized Trial. |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02302703 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Hadas Lemberg, PhD |
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Address:
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Telephone:
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00 972 2 6777572 |
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Email:
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lhadas@hadassah.org.il |
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Affiliation:
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Name:
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Michael Wilschanski, Prof |
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Address:
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Telephone:
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9722-5845039 |
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Email:
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michaelwil@hadassah.org.il |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- children who answer the pediatric ROME III criteria for IBS
Exclusion Criteria:
- Other diagnosis (e.g. inflammatory bowel disease, celiac disease).
- Patient receiving chronic medical therapy.
- Patient already on a restrictive diet (e.g. gluten-free, lactose-free)
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in Children
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Intervention(s)
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Other: low FODMAP diet vs Gluten free diet
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Primary Outcome(s)
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abdominal pain score
[Time Frame: 7 days]
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Secondary ID(s)
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fodmap1-HMO-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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