Nutritional Adequacy of a FODMAP Diet in Children
Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJune 4, 2015
June 1, 2015
1.4 years
April 9, 2014
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 6 weeks
Secondary Outcomes (2)
Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools
Baseline, 6 weeks
Anthropometry: weight and mid-arm circumference
Baseline, 6 weeks
Study Arms (1)
FODMAP's diet
OTHERA diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr Anne Paynelead
- University of Londoncollaborator
Study Sites (1)
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne Payne, PhD
University of Plymouth
- PRINCIPAL INVESTIGATOR
Claire de Koker, BSc (Hons)
Chelsea and Westminster NHS Foundation Trust, UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor/Academic Lead for Nutrition & Dietetics
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 17, 2014
Study Start
February 1, 2014
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
June 4, 2015
Record last verified: 2015-06