Clinical trial NCT04515940: Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorder, Child
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-08-17
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: paediatric children 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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: Day 7 from baseline
measure: Compliance
timeFrame: Day 7 from baseline
Secondary outcomes:
measure: weight in kg
timeFrame: Day 8 from baseline
measure: height in meters
timeFrame: Day 8 from baseline
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Nutrition and Dietetics
state: Sussex
Study officials:
affiliation: Nutrition and Dietetics
name: Chris Smith
role: PRINCIPAL_INVESTIGATOR
References: