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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children

Conditions
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Functional Abdominal Pain Syndrome

Intervention / Treatment
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* Other: The low FODMAP diet.
* Other: The diet based on NICE guidelines.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAP diet group<br>four weeks of the low FODMAP diet based on Monash University low FODMAP diet App. | Other: The low FODMAP diet.<br>* 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.<br>|
| Active Comparator: Control group<br>four weeks of the diet based on NICE guidelines and contained products with different FODMAP content | Other: The diet based on NICE guidelines.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of abdominal pain severity | 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of abdominal pain and defecation frequency | Abdominal pain and defecation frequency were recorded as number per day. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low FODMAP diet, functional abdominal pain, children