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Nutritional Adequacy of a FODMAP Diet in Children

Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02117180
Enrollment
15
Registered
2014-04-17
Start date
2014-02-28
Completion date
2015-08-31
Last updated
2015-06-04

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

Conditions

Functional Gastrointestinal Disorders in Children

Keywords

functional gastrointestinal disorders, FGID, children, FODMAP

Brief summary

This pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. A larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.

Interventions

OTHERFODMAP's diet

The safety and efficacy of a low FODMAP diet will be evaluated in a convenience sample of children with functional gastrointestinal disorders, over a 6 week intervention period.

Sponsors

University of London
CollaboratorOTHER
Dr Anne Payne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 10-16 years * Informed consent and assent obtained * Patients with diagnosed FGID according to Rome III criteria: i.e. category H2b (irritable bowel syndrome) and H2d (childhood functional abdominal pain)

Exclusion criteria

* Patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease) * Patients with food allergies * Patients with a weight for age below -2 Standard Deviations (SD) (below 0.4th centile) on the UK WHO growth charts. * Patients with known micronutrient deficiencies determined by blood levels prior to study * Patients without informed consent and assent obtained

Design outcomes

Primary

MeasureTime frameDescription
Energy and nutrient intakeBaseline, 6 weeksEnergy and nutrient intake will be assessed using a 4-day estimated food diary at baseline and 6-weeks after dietary intervention. Comparison will be made between baseline and 6-week data and with United Kingdom (UK) Reference Nutrient Intakes.

Secondary

MeasureTime frameDescription
Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stoolsBaseline, 6 weeksPracticality of the FODMAP diet will be evaluated using a standardised structured questionnaire. The impact of a low FODMAP diet on FGID symptoms and stools will be assessed using a validated symptom questionnaire and the Bristol Stool Chart. The impact of a low FODMAP diet on quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module.
Anthropometry: weight and mid-arm circumferenceBaseline, 6 weeksAnthropometric measurements will be taken at baseline and 6 weeks after dietary intervention. Comparison will be made between baseline and 6-week data for weight and mid upper arm circumference, as well as comparing both baseline and 6-week data to the UK-WHO growth standards.

Countries

United Kingdom

Contacts

Primary ContactClaire de Koker, BSc (Hons)
claire.dekoker@chelwest.nhs.uk(+44)208 746 8173

Outcome results

None listed

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