No registrations found.
ID
Source
Brief title
Health condition
1. Tube fed;
2. children aged 7-12 years;
3. cerebral palsy.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gut microflora.
Secondary outcome
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.
Background summary
At 0, 3, 4 and 7 months, subjects visited the clinic for anthropometric and body composition measurements, blood parameters and stool microflora analysis. 48 hr dietary recall was performed preceding each visit. Stool characteristics and gastrointestinal discomfort were reported.
Study objective
Improvement of the intestinal microflora of children consuming a fibre-enriched versus a standard paediatric tube feed.
Study design
N/A
Intervention
Duration intervention: 7 Months.
Two paediatric tube feeds:
1. Fibre-enriched;
2. Standard (fibre-free).
PO Box 7005
Jane McKenzie
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl
PO Box 7005
Jane McKenzie
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL706 |
| NTR-old | NTR716 |
| Other | : Project Number 100013. |
| ISRCTN | Incomplete info for ISRCTN |