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Effect of a fibre-enriched versus standard pediatric tube feed on the intestinal flora, gastrointestinal function and nutritional status of 7-12 year old children.


- candidate number2146
- NTR NumberNTR716
- ISRCTNIncomplete info for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jun-2006
- Secondary IDsProject Number 100013. 
- Public TitleEffect of a fibre-enriched versus standard pediatric tube feed on the intestinal flora, gastrointestinal function and nutritional status of 7-12 year old children.
- Scientific TitleEffect of a fibre-enriched versus standard pediatric tube feed on the intestinal flora, gastrointestinal function and nutritional status of 7-12 year old children.
- ACRONYMTentrini Study.
- hypothesisImprovement of the intestinal microflora of children consuming a fibre-enriched versus a standard paediatric tube feed.
- Healt Condition(s) or Problem(s) studiedCerebral palsy
- Inclusion criteriaChildren:
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 criteriaChildren:
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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2003
- planned closingdate31-dec-2005
- Target number of participants27
- InterventionsDuration intervention: 7 Months.
Two paediatric tube feeds:
1. Fibre-enriched;
2. Standard (fibre-free).
- Primary outcomeGut microflora.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Jane McKenzie
- CONTACT for SCIENTIFIC QUERIESPhD. Laurent Béghin
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryAt 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.
- Main changes (audit trail)
- RECORD23-jun-2006 - 1-okt-2008


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