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

Société des Produits Nestlé (SPN)21 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Nutrition Disorder, Child

Interventions

acceptability, tolerance and palatability studyDIETARY_SUPPLEMENT

prospective acceptability study

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Nutrition and Dietetics

Brighton, Sussex, United Kingdom

Outcomes

Primary Outcomes

Gastrointestinal tolerance

Daily record via participant diary: 1. Gastrointestinal tolerance: * Diarrhoea and / or constipation * Bloating and / or distension * Nausea and / or vomiting * Burping / flatulence / regurgitation * Abdominal discomfort / pain/ back arching/ crying 2. Participant compliance: How many feeds taken and volume prescribed each day 3. 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

Time frame: Day 7 from baseline

Compliance

volume suggested versus consumed

Time frame: Day 7 from baseline

Secondary Outcomes

weight in kg

At baseline

Time frame: Day 8 from baseline

height in meters

At basline

Time frame: Day 8 from baseline

Data from ClinicalTrials.gov

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