Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR451; 100027
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Received from local medical ethics committee
Study design
Multicentre, randomised, single blind, active controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2005
Overall trial end date
01/10/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
24
Participant 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
Recruitment start date
01/10/2005
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Numico Research B.V.
Wageningen
6700 CA
Netherlands
Funders
Funder type
Industry
Funder name
Numico Research B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list