Tolerance and safety study of a new paediatric peptide feed
| ISRCTN | ISRCTN48462333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48462333 |
| Protocol serial number | NTR451; 100027 |
| Sponsor | Numico Research B.V. (Netherlands) |
| Funder | Numico Research B.V. (Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single blind, active controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Paediatric peptide feed |
| 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 a 3-month open extension of the study. |
| Intervention type | Other |
| Primary outcome measure(s) |
Total score on questionnaire on gastro-intestinal tolerance: diarrhoea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds. |
| Key secondary outcome measure(s) |
1. Stool output (frequency, volume and consistency) of paediatric peptide feed versus control feeds |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 24 |
| Key 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 |
| Key exclusion criteria | 1. 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6700 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
