Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Child Nutrition Disorders
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- Participant compliance
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Participant compliance
Time Frame: Day 7 from baseline
Volume of test product prescribed versus actually taken
Gastrointestinal tolerance
Time Frame: Day 7 from baseline
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.
Secondary Outcomes
- Body Weight(Day 7 from baseline)