Tolerance and safety study of a new paediatric peptide feed
| ISRCTN | ISRCTN48462333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48462333 |
| Secondary identifying numbers | NTR451; 100027 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maartje Jansen
Scientific
Scientific
Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
Study information
| Study design | Multicentre, randomised, single blind, active controlled, crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Total score on questionnaire on gastro-intestinal tolerance: diarrhoea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds. |
| Secondary outcome measures | 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, haemoglobin, 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 |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 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
Numico Research B.V.
Wageningen
6700 CA
Netherlands
6700 CA
Netherlands
Sponsor information
Numico Research B.V. (Netherlands)
Industry
Industry
P.O. Box 7005
Wageningen
6700 CA
Netherlands
"ROR" |
https://ror.org/00aj77a24 |
|---|
Funders
Funder type
Industry
Numico Research B.V. (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
