Status:
COMPLETED
Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Nutrition Disorder, Child
Eligibility:
All Genders
1-10 years
Brief Summary
This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of ...
Detailed Description
Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based oral nutritional supplement drink for the dietary management. The ACBS requirement for evaluable data on 15 p...
Eligibility Criteria
Inclusion
- I. Children aged 1 year and over who require 1-3 bottles of an oral nutritional peptide based supplement drink II. Children who require an oral nutritional supplement or who are already established on a nutritional supplement drink III. Children who require a nutritional supplement drink as bolus feeding via a feeding tube.
- IV. Children being able to communicate views of acceptability V. Willingly given, written, informed consent from patient or parent/guardian. VI. Willingly given, written assent (if appropriate).
Exclusion
- I. Inability to comply with the study protocol, in the opinion of the investigator.
- II. Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Require a milk free diet IV. Children under the age of 12 months V. Emergencies
Key Trial Info
Start Date :
October 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 29 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04515940
Start Date
October 30 2019
End Date
September 29 2020
Last Update
October 22 2024
Active Locations (1)
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1
Nutrition and Dietetics
Brighton, Sussex, United Kingdom, BN2 5BE