Tolerance and safety study of a new paediatric peptide feed

Completed

• Conditions: Paediatric peptide feed; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN48462333
• Lead Sponsor: umico Research B.V. (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified