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

NCT04515940 | Completed

• 1 other identifier: ONS peptide 1.5
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Nutrition Disorder, Child

Outcome Measures

Primary Outcomes (2)

• 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

  Day 7 from baseline

• Compliance

  volume suggested versus consumed

  Day 7 from baseline

Secondary Outcomes (2)

• weight in kg

  Day 8 from baseline

• height in meters

  Day 8 from baseline

Interventions

acceptability, tolerance and palatability study DIETARY_SUPPLEMENT

prospective acceptability study

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

paediatric children 1- 10 years

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nutrition and Dietetics

Brighton, Sussex, BN2 5BE, United Kingdom

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Drug Tolerance

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Chris Smith

  Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: August 17, 2020
• Study Start: October 30, 2019
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)