N/A
ID
Bron
Verkorte titel
Aandoening
Children requiring a paediatric peptide feed for at least 8 weeks. This can be due to causes such as inflammatory bowel disease, short bowel syndrome, pancreas/liver disease, chronic diarrhoea, cystic fibrosis, undiagnosed gut problems, coeliac disease.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total score on questionnaire on gastro-intestinal tolerance: diarrhea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
N/A
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
After baseline measurements, patients receive either their current feed (= control) for 4 weeks followed by 4 weeks paediatric peptide feed, or paediatric peptide feed for 4 weeks followed by 4 weeks on the control feed. After 4 weeks and after 8 weeks, children return to the clinic where the outcome measures are assessed. Children are invited to participate in an 3-month open extension of the study.
Publiek
P.O. Box 7005
Maartje Jansen
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
Wetenschappelijk
P.O. Box 7005
Maartje Jansen
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Children requiring a paediatric peptide feed. Some conditions where this is required may include inflammatory bowel disease, short bowel syndrome, pancreas/liver disease, chronic diarrhoea, cystic fibrosis, undiagnosed gut problems, coeliac disease;
2. Approximately 8-30 kg in weight;
3. Peptide based feed prescribed for at least 50% of daily energy requirements;
4. Expected need of peptide based feed for a minimum of 2 months;
5. Written parental informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Unsuitable for infants under 1 year of age;
2. Children receiving parenteral nutrition for more than 50% energy requirements;
3. Children with galactosaemia;
4. Children with cow milk allergy;
5. Children with medical or dietary contraindication;
6. If the investigator is, for any reason, uncertain about the willingness to comply with the protocol requirements, the subject can be excluded;
7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
8. Multiple allergies.
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 | NL411 |
| NTR-old | NTR451 |
| Ander register | : 100027 |
| ISRCTN | ISRCTN48462333 |