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This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
Patients well established and stable on a standard enteral tube feed will be changed to a paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula, a nutritionally complete standard enteral tube feed.
The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms, current oral intake and weight at the start of the study.
The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric formula | Other | Each child will receive a new formula for a period of seven days. The new formula is a nutritionally complete standard enteral tube feed, with ingredients derived from real food. The formula is a food for special medical purposes for use under medical supervision. The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric Formula | Other | One week intake diary, one week tolerance diary, product intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance | Incidence of gastrointestinal adverse effects. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study. | Day 7 from baseline |
| Participant compliance | Volume of test product prescribed versus actually taken | Day 7 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Weight will be measured in Kg | Day 7 from baseline |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clare Thornton-Wood, BSc | Dietitian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evelina Childrens Hospital | London | SE1 7EH | United Kingdom | |||
| Chelsea and Westminster Hospital |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| London |
| SW10 9NH |
| United Kingdom |
| East Oxford Health Centre | Oxford | OX4 1XD | United Kingdom |