No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total score on questionnaire on gastro-intestinal tolerance: diarrhea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds.
Secondary outcome
1. Stool output (frequency, volume and consistency) of paediatric peptide feed versus control feeds;
2. Mean change in weight (kg) of paediatric peptide feed versus control feeds;
3. Mean change in growth, expressed as z-scores for weight and height (head circumference for children younger than two years old) of paediatric peptide feed versus control feeds;
4. Mean change in triceps skin fold thickness and mid arm circumference of paediatric peptide feed versus control feeds;
5. Blood concentrations of serum albumin, hemoglobin, haematocrit and c-reactive protein (CRP) of paediatric peptide feed versus control feeds;
6. Convenience/ease of use of paediatric peptide feed versus control feeds;
7. Dietary intake of paediatric peptide feed versus control feeds.
Background summary
N/A
Study objective
N/A
Study design
N/A
Intervention
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.
P.O. Box 7005
Maartje Jansen
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
P.O. Box 7005
Maartje Jansen
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL411 |
| NTR-old | NTR451 |
| Other | : 100027 |
| ISRCTN | ISRCTN48462333 |