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

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

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.

Study Overview

• Status: Completed
• Conditions: Functional Abdominal Pain Syndrome
• Intervention / Treatment: Other: The low FODMAP diet.; Other: The diet based on NICE guidelines.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Olsztyn, Poland, 10-561
    • Regional Specialized Children'S Hospital
  • Olsztyn, Poland, 10-719
    • University of Warmia and Mazury

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low FODMAP diet group; four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.	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.
Active Comparator: Control group; four weeks of the diet based on NICE guidelines and contained products with different FODMAP content	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of stool consistency	Stool consistency was assessed using the validated Bristol Stool Form Scale. Type 1 or 2 were classified as the hard or lumpy stool, type 6 or 7 as the loose or waterly stool, and type 3-5 as the normal stool.	6 weeks
Assessment of nutritional status	Parameters of nutritional status before diet: weight (kilograms), height (meters).	4 months
Assessment of physical activity	The level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)	4 months
Assessment of well-being of the patient	Declarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')	3 weeks

Collaborators and Investigators

• Sponsor: University of Warmia and Mazury
• Collaborators: National Science Centre, Poland
• Investigators: Principal Investigator: Katarzyna M Boradyn, MSc, Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury; Principal Investigator: Elżbieta Jarocka-Cyrta, Ph.D, Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum Faculty of Medicine, University of Warmia and Mazury; Principal Investigator: Katarzyna E Przybyłowicz, Ph.D, Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2017
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: children; functional abdominal pain; low FODMAP diet
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: 2015/17/N/NZ5/02596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No