Improvement of the intestinal microflora of children consuming a fibre-enriched versus a standard paediatric tube feed.
ID
Bron
Verkorte titel
Aandoening
1. Tube fed;
2. children aged 7-12 years;
3. cerebral palsy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Gut microflora.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Improvement of the intestinal microflora of children consuming a fibre-enriched versus a standard paediatric tube feed.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Duration intervention: 7 Months.
Two paediatric tube feeds:
1. Fibre-enriched;
2. Standard (fibre-free).
Publiek
PO Box 7005
Jane McKenzie
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl
Wetenschappelijk
PO Box 7005
Jane McKenzie
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL706 |
NTR-old | NTR716 |
Ander register | : Project Number 100013. |
ISRCTN | Incomplete info for ISRCTN |