Nutritional Adequacy of a FODMAP Diet in Children

Dr Anne Payne

Status and phase: Unknown; Phase 1

Conditions: Functional Gastrointestinal Disorders in Children

Treatments: Other: FODMAP's diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02117180

CdeK2014

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

FODMAP's diet

Other group

Description:

A diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs)

Treatment:

Other: FODMAP's diet