Child Nutrition Disorders
Conditions
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.
Interventions
OTHERPediatric Formula
One week intake diary, one week tolerance diary, product intake
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Require a tube feed (taking \>75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition * Paediatrics aged 1 year above. * Patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on current formula) * Willingly given, written, informed consent from patient or parent/guardian. * Willingly given, written assent (if appropriate).
Exclusion criteria
* Inability to comply with the study protocol, in the opinion of the investigator * Known food allergies to any ingredients (see ingredients list) * Patients with significant renal or hepatic impairment * Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file). * Participation in another interventional study within 2 weeks of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | 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. |
| Participant compliance | Day 7 from baseline | Volume of test product prescribed versus actually taken |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Day 7 from baseline | Weight will be measured in Kg |
Countries
United Kingdom
Outcome results
None listed