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Completed

NCT Number: NCT04515940

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

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).

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Key information

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nutrition and Dietetics

Brighton, Sussex, BN2 5BE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acceptability, tolerance and palatability study

Dietary Supplement

prospective acceptability study

Primary outcomes

  1. Gastrointestinal tolerance

    Time frame: Day 7 from baseline

    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

  2. Compliance

    Time frame: Day 7 from baseline

    volume suggested versus consumed

Secondary outcomes

  1. weight in kg

    Time frame: Day 8 from baseline

    At baseline

  2. height in meters

    Time frame: Day 8 from baseline

    At basline

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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