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

Not Applicable

Completed

• Conditions: Functional Abdominal Pain Syndrome
• Interventions: Other: The low FODMAP diet.; Other: The diet based on NICE guidelines.

• Registration Number: NCT03771027
• Lead Sponsor: University of Warmia and Mazury

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-08
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Status Verified: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-07
• Last Update Submitted: 2018-12-07
• Study First Posted: 2018-12-10
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low FODMAP diet group	The low FODMAP diet.	four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
Control group	The diet based on NICE guidelines.	four weeks of the diet based on NICE guidelines and contained products with different FODMAP content

Primary Outcome Measures

Name	Time	Method
Assessment of abdominal pain severity	6 weeks	Wong-Baker FACES Pain Rating Scale where 0 = no hurt and 10 = hurts worst was used for assessed severity of abdominal pain during the 6-week study period (2 weeks before and 4 weeks during the diet)

Secondary Outcome Measures

Name	Time	Method
Assessment of abdominal pain and defecation frequency	6 weeks	Abdominal pain and defecation frequency were recorded as number per day.

Trial Locations

Locations (2)

Regional Specialized Children's Hospital; 🇵🇱 Olsztyn, Poland

University of Warmia and Mazury; 🇵🇱 Olsztyn, Poland