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

U

University of Warmia and Mazury

Status

Completed

Conditions

Functional Abdominal Pain Syndrome

Treatments

Other: The diet based on NICE guidelines.
Other: The low FODMAP diet.

Study type

Interventional

Funder types

Other

Identifiers

NCT03771027
2015/17/N/NZ5/02596

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • functional abdominal pain according to Rome III criteria
  • consent to participate in the study
  • positive decision of gastroenterologist concerning enrolment of the patient to the trial

Exclusion criteria

  • organic causes for gastrointestinal tract disorders,
  • occurrence of an abdominal migraine, IBS, food allergies or intolerances, other significant disorders, acute infection
  • antibiotic treatment within the last 8 weeks

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

33 participants in 2 patient groups

Low FODMAP diet group
Experimental group
Description:
four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
Treatment:
Other: The low FODMAP diet.
Control group
Active Comparator group
Description:
four weeks of the diet based on NICE guidelines and contained products with different FODMAP content
Treatment:
Other: The diet based on NICE guidelines.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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