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Nutritional Adequacy of a FODMAP Diet in Children

Primary Purpose

Functional Gastrointestinal Disorders in Children

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
FODMAP's diet
Sponsored by
Dr Anne Payne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders in Children focused on measuring functional gastrointestinal disorders, FGID, children, FODMAP

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Chelsea and Westminster NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FODMAP's diet

Arm Description

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

Outcomes

Primary Outcome Measures

Energy and nutrient intake
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

Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools
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.
Anthropometry: weight and mid-arm circumference
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.

Full Information

First Posted
April 9, 2014
Last Updated
June 3, 2015
Sponsor
Dr Anne Payne
Collaborators
University of London
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1. Study Identification

Unique Protocol Identification Number
NCT02117180
Brief Title
Nutritional Adequacy of a FODMAP Diet in Children
Official Title
Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Anne Payne
Collaborators
University of London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders in Children
Keywords
functional gastrointestinal disorders, FGID, children, FODMAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FODMAP's diet
Arm Type
Other
Arm Description
A diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs)
Intervention Type
Other
Intervention Name(s)
FODMAP's diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Energy and nutrient intake
Description
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.
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools
Description
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.
Time Frame
Baseline, 6 weeks
Title
Anthropometry: weight and mid-arm circumference
Description
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.
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire de Koker, BSc (Hons)
Phone
(+44)208 746 8173
Email
claire.dekoker@chelwest.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Payne, PhD
Organizational Affiliation
University of Plymouth
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claire de Koker, BSc (Hons)
Organizational Affiliation
Chelsea and Westminster NHS Foundation Trust, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chelsea and Westminster NHS Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire de Koker, BSc (Hons)
Phone
(+44) 208 746 8173
Email
claire.dekoker@chelwest.nhs.uk
First Name & Middle Initial & Last Name & Degree
Claire de Koker, BSc (Hons)

12. IPD Sharing Statement

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Nutritional Adequacy of a FODMAP Diet in Children

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