Nutritional Adequacy of a FODMAP Diet in Children

NCT ID: NCT02117180

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Functional Gastrointestinal Disorders in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FODMAP's diet

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

Group Type OTHER

FODMAP's diet

Intervention Type OTHER

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.

Interventions

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FODMAP'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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of London

OTHER

Sponsor Role collaborator

Dr Anne Payne

OTHER

Sponsor Role lead

Responsible Party

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Dr Anne Payne

Associate Professor/Academic Lead for Nutrition & Dietetics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anne Payne, PhD

Role: STUDY_DIRECTOR

University of Plymouth

Claire de Koker, BSc (Hons)

Role: PRINCIPAL_INVESTIGATOR

Chelsea and Westminster NHS Foundation Trust, UK

Locations

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Chelsea and Westminster NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Claire de Koker, BSc (Hons)

Role: CONTACT

(+44)208 746 8173

Facility Contacts

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Claire de Koker, BSc (Hons)

Role: primary

(+44) 208 746 8173

Other Identifiers

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CdeK2014

Identifier Type: -

Identifier Source: org_study_id

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