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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03771027
Enrollment
33
Registered
2018-12-10
Start date
2017-07-08
Completion date
2017-12-08
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Abdominal Pain Syndrome

Keywords

low FODMAP diet, functional abdominal pain, children

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.

Interventions

OTHERThe 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.

OTHERThe 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.

Sponsors

National Science Centre, Poland
CollaboratorOTHER_GOV
University of Warmia and Mazury
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of abdominal pain severity6 weeksWong-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

MeasureTime frameDescription
Assessment of abdominal pain and defecation frequency6 weeksAbdominal pain and defecation frequency were recorded as number per day.

Other

MeasureTime frameDescription
Assessment of stool consistency6 weeksStool 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.
Assessment of nutritional status4 monthsParameters of nutritional status before diet: weight (kilograms), height (meters).
Assessment of physical activity4 monthsThe level of physical activity was established used the MVPA indicator (Moderate to Vigorous Physical Activity)
Assessment of well-being of the patient3 weeksDeclarations of parents about symptoms changes in children during diet intervention based on a seven-point Likert scale (from 'much worse' to 'never occurred')

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026