Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of London | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FODMAP's diet | Other | A diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FODMAP's diet | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire de Koker, BSc (Hons) | Contact | (+44)208 746 8173 | claire.dekoker@chelwest.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Anne Payne, PhD | University of Plymouth | Study Director |
| Claire de Koker, BSc (Hons) | Chelsea and Westminster NHS Foundation Trust, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster NHS Foundation Trust | Recruiting | London | SW10 9NH | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 17, 2017 | |
| Reset | Apr 27, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 17, 2017 | Apr 27, 2017 |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 6 weeks |
| 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 |