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Tolerance and safety study of a new paediatric peptide feed.


- candidate number1748
- NTR NumberNTR451
- ISRCTNISRCTN48462333
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR7-okt-2005
- Secondary IDs100027 
- Public TitleTolerance and safety study of a new paediatric peptide feed.
- Scientific TitleTolerance and safety study of a new paediatric peptide feed.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPeptides
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate1-okt-2006
- Target number of participants24
- InterventionsAfter 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.
- Primary outcomeTotal score on questionnaire on gastro-intestinal tolerance: diarrhea, constipation, nausea, vomiting, abdominal distention, flatulence and burping of paediatric peptide feed versus control feeds.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Maartje Jansen
- CONTACT for SCIENTIFIC QUERIESDr. Anil Dhawan
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD7-okt-2005 - 2-sep-2009


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