Children in need of oral nutritional support
Conditions
Interventions
Test-product: A new paediatric sip feed that is nutritionally complete and energy dense (1.5 kcal/ml). Amount: As pre-scribed by Health Care Professional.
Control-product: A standard fibre-enriched p
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, aged 3-12 years (including 3 and 12 years) in need of oral nutritional support (subject can be current or new paediatric sip feed user); 2. Subject requires a paediatric sip feed for at least 6 weeks; 3. Both hospitalized subjects and out-patients; 4. Stable health status and expected to remain stable throughout the study (in the opinion of the Health Care Professional); 5. Written informed consent from parents/guardian and subject (if applicable according to local law).
Exclusion criteria
Exclusion criteria: 1. Cow’s milk allergy, known inflammatory bowel diseases, bowel resection; 2. Subjects requiring a fibre-free diet; 3. Known allergy for fruit (apple, pear, strawberry, raspberry, banana, apricot, lemon) and/or carrot; 4. Subjects requiring an adult rather than a paediatric sip feed; 5. Major renal dysfunction (if requiring, but not yet receiving, dialysis); 6. Major hepatic dysfunction (e.g. hepatitis, congenital abnormalities affecting the liver); 7. Major gastrointestinal intolerance (e.g. vomiting, diarrhoea); 8. Inherited metabolic disorders, including galactosaemia; 9. Use of parenteral feeding and/or enteral tube-feeding; 10. Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements; 11. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance: Daily stool frequency (with diary) and frequency and intensity of gastro-intestinal symptoms (with questionnaire). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Product appreciation: Overall liking and product evaluation carer (both with questionnaire); 2. Daily study product intake (with diary). | — |
Contacts
Public ContactHeidi Sonnemans
PO box 7005
Outcome results
None listed