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Clinical Trials/ISRCTN48462333
ISRCTN48462333
Completed
Not Applicable

Tolerance and safety study of a new paediatric peptide feed

umico Research B.V. (Netherlands)0 sites24 target enrollmentJanuary 27, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
umico Research B.V. (Netherlands)
Enrollment
24
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
umico Research B.V. (Netherlands)

Eligibility Criteria

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\. 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

Outcomes

Primary Outcomes

Not specified

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