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

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

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).

Study Overview

• Status: Completed
• Conditions: Nutrition Disorder, Child
• Intervention / Treatment: Dietary supplement: acceptability, tolerance and palatability study

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • Sussex
    • Brighton, Sussex, United Kingdom, BN2 5BE
      • Nutrition and Dietetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

paediatric children 1- 10 years

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal tolerance	Daily record via participant diary: Gastrointestinal tolerance:Diarrhoea and / or constipationBloating and / or distensionNausea and / or vomitingBurping / flatulence / regurgitationAbdominal 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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Chris Smith, Nutrition and Dietetics

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2019
• Primary Completion (ACTUAL): September 29, 2020
• Study Completion (ACTUAL): September 29, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (ACTUAL): August 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Child Nutrition Disorders
• Other Study ID Numbers: ONS peptide 1.5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No