Nutritional Adequacy of a FODMAP Diet in Children

June 3, 2015 updated by: Dr Anne Payne

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Recruiting
        • Chelsea and Westminster NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Claire de Koker, BSc (Hons)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: FODMAP's diet
A diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy and nutrient intake
Time Frame: 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.
Baseline, 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Anne Payne

Collaborators

University of London

Investigators

  • Study Director: Anne Payne, PhD, University of Plymouth
  • Principal Investigator: Claire de Koker, BSc (Hons), Chelsea and Westminster NHS Foundation Trust, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (ESTIMATE)

April 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CdeK2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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