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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.

NCT02302703 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-03

No results posted yet for this study

Summary

Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be relieved with defecation and a change in stool frequency and consistency. Its prevalence among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is defined as gastrointestinal symptoms which increase with eating gluten-containing foods and improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and polyols) are carbohydrates that are not absorbed well in the small intestines, therefore fermented by gut microbiota, increasing osmotic load at the intestine causing fluid shift and gas production. The patient suffers bloating, abdominal pain, flatulence and change of stool consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes, artificial sweeteners and soft drinks.

Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on research in adults.

Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric gastroenterology team at Hadassah. All children will record one week of baseline diet and symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week, together with a washout period of one week between the diets. During the two weeks of intervention diets, the children aided by their parents will document and score symptoms (bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure the anticipated influence of each diet against baseline diet and symptoms.

Expected results: In previous studies, a change in symptoms was viewed within a few days. We expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.

Conditions

  • Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in Children

Interventions

OTHER

low FODMAP diet vs Gluten free diet

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302703 on ClinicalTrials.gov