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

Nutrition Disorder, Child Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515940
• Other study ID #: ONS peptide 1.5
• Status: Completed
• Start date: October 30, 2019
• Est. completion date: September 29, 2020

Study information

• Verified date: March 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorder, Child
• Nutrition Disorders

Intervention

Dietary Supplement:
• acceptability, tolerance and palatability study
prospective acceptability study

Locations

Country	Name	City	State
United Kingdom	Nutrition and Dietetics	Brighton	Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Compliance	volume suggested versus consumed	Day 7 from baseline
Secondary	weight in kg	At baseline	Day 8 from baseline
Secondary	height in meters	At basline	Day 8 from baseline