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

NCT03771027 | Completed

• 1 other identifier: 2015/17/N/NZ5/02596
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Functional Abdominal Pain Syndrome

Keywords

low FODMAP diet; functional abdominal pain; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of abdominal pain and defecation frequency

  6 weeks

Other Outcomes (4)

• Assessment of stool consistency

  6 weeks

• Assessment of nutritional status

  4 months

• Assessment of physical activity

  4 months

Study Arms (2)

Low FODMAP diet group

EXPERIMENTAL

four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.

Other: The low FODMAP diet.

Control group

ACTIVE COMPARATOR

four weeks of the diet based on NICE guidelines and contained products with different FODMAP content

Other: The diet based on NICE guidelines.

Interventions

The low FODMAP diet. OTHER

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.

Low FODMAP diet group

The diet based on NICE guidelines. OTHER

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.

Control group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warmia and Mazury: lead
• National Science Centre, Poland: collaborator

Study Sites (2)

Regional Specialized Children's Hospital

Olsztyn, 10-561, Poland

Location

University of Warmia and Mazury

Olsztyn, 10-719, Poland

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: July 8, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)