Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children

Study Overview
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Brief Summary
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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 age. The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Detailed Description
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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 participants has informed the trial's recruitment target; however, we may need to exceed this target if any patients give their consent to join the study but then decide not to participate in the study. Participants who join the study and begin using the product would count towards the recruitment total and their data would be included in a submission to the ACBS whether they complete the 7-day study period or not. Each potential participant must meet all of the inclusion criteria and not meet any of the exclusion criteria.

Official Title
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Evaluation of the Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children Over 12 Months of Age

Conditions
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Nutrition Disorder, Child

Intervention / Treatment
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* Dietary Supplement: acceptability, tolerance and palatability study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: acceptability, tolerance and palatability study|prospective acceptability study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Daily record via participant diary: Gastrointestinal tolerance: Diarrhoea and / or constipation Bloating and / or distension Nausea and / or vomiting Burping / flatulence / regurgitation Abdominal discomfort / pain/ back arching/ crying Participant compliance: How many feeds taken and volume prescribed each day Acceptability Questionnaires to children and or parents for the evaluation of the acceptability and ease of use of the milk supplement drink Diarrhoea, constipation, bloating, distension, nausea, vomitting, burping, abdominal pain | Day 7 from baseline | 
| Compliance | volume suggested versus consumed | Day 7 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight in kg | At baseline | Day 8 from baseline | 
| height in meters | At basline | Day 8 from baseline |