Nutritional Adequacy of a FODMAP Diet in Children

Phase 1

• Conditions: Functional Gastrointestinal Disorders in Children
• Interventions: Other: FODMAP's diet

• Registration Number: NCT02117180
• Lead Sponsor: Dr Anne Payne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FODMAP's diet	FODMAP's diet	A diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs)

Primary Outcome Measures

Name	Time	Method
Energy and nutrient intake	Baseline, 6 weeks	Energy 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 Outcome Measures

Name	Time	Method
Anthropometry: weight and mid-arm circumference	Baseline, 6 weeks	Anthropometric 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.
Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools	Baseline, 6 weeks	Practicality 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.

Trial Locations

Locations (1)

Chelsea and Westminster NHS Foundation Trust; 🇬🇧 London, United Kingdom