1. Tube fed
Conditions
Interventions
Duration intervention: 7 Months.
Two paediatric tube feeds:
1. Fibre-enriched
2. Standard (fibre-free).
Sponsors
Numico Research B.V.
Eligibility
Inclusion criteria
Inclusion criteria: Children: 1. male and female subjects, aged 7-12 years, who are expected to need tube feeding for at least 8 months; 2. >12 years of age, but with an age-weight status comparable to 7-12 years (21-45kg) are eligible; 3. currently tube fed with a fibre-free formula for the last 2 (or more) weeks; 4. for whom tube feeding contributes to at least 50% of total energy intake; 5. who are stable with respect to their disease/pathological condition; 6. whose daily nutritional intake is stable during the study period; 7. written parental informed consent.
Exclusion criteria
Exclusion criteria: Children: 1. with Cow’s Milk Allergy, inflammatory bowel disease or bowel resection; 2. requiring a fibre-free diet; 3. on antibiotic therapy during the 2 weeks preceding the study; 4. using laxative therapy other than polyethylene glycol or paraffin oil during the 2 weeks preceding the study; 5. with acute diarrhoea during the 2 weeks preceding the study; 6. consuming more than 1 serving of yoghurt or fermented dairy product during the 2 weeks preceding the study; 7. receiving supplementation with Fe and/or any of the other monitored micronutrients during the month prior to inclusion; 8. with disease associated gastro-intestinal disorders (short-bowel disease, malabsorption, cystic fibrosis); 9. with known dislipoprotidemia; 10. participating simultaneously in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microflora. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bowel function: stool frequency, consistency and reduction of laxative use; 2. Gastro-intestinal intolerance (eg: bloating, abdominal pain, nausea); 3. Nutritional status, assessed by measuring anthropometrics, micronutrient status and body composition. | — |
Contacts
Public ContactJane McKenzie
Numico Research B.V., PO Box 7005
Outcome results
None listed