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Therapeutic Effect of the Low FODMAP Diet in Children With Functional Abdominal Pain.

NCT03771027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-12-10

No results posted yet for this study

Summary

Diet components are important factors in pathogenesis of functional gastrointestinal disorders, especially in the irritable bowel syndrome. Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) are a group of short chain, poorly absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms because of rapid fermentation in different segments of the gut. Low FODMAP diet is a novel treatment option with proven efficacy in reducing symptoms of functional gastrointestinal disorders in adults. Conversely, although functional abdominal pain is a common health problem in children, the efficacy of a low FODMAP diet remains understudied in this population.

The aim of this study was to compare the effects of two diets: a low FODMAP diet and a diet based on standard dietary advice of the National Institute for Health and Care Excellence (NICE), on abdominal symptoms in children with functional abdominal pain.

Conditions

  • Functional Abdominal Pain Syndrome

Interventions

OTHER

The low FODMAP diet.

The low FODMAP group had reduced the intake of FODMAP. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.

OTHER

The diet based on NICE guidelines.

The control group based on NICE guidelines received diet contained products with different FODMAP content. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.

Sponsors & Collaborators

  • National Science Centre, Poland

    collaborator OTHER_GOV

  • University of Warmia and Mazury

    lead OTHER

Principal Investigators

  • Katarzyna M Boradyn, MSc · Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury

  • Elżbieta Jarocka-Cyrta, Ph.D · Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury

  • Katarzyna E Przybyłowicz, Ph.D · Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-08
Primary Completion
2017-12-08
Completion
2017-12-08

Countries

  • Poland

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 NCT03771027 on ClinicalTrials.gov