Functional Gastrointestinal Disorders in Children Clinical Trial
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.
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.
| Status | Unknown status |
| Enrollment | 15 |
| Est. completion date | August 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 16 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Chelsea and Westminster NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Dr Anne Payne | University of London |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |
Baseline, 6 weeks | |
| Secondary | 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. | Baseline, 6 weeks |