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Completed

NCT Number: NCT05026476

Acceptability and Tolerance Study of a Thickener

This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chelsea and Westminster Hospital Foundation Trust

London, SW10 9NH, United Kingdom

About this study

To evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the submission to the Advisory Committee for Borderline Substances (ACBS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

I. Infants and children aged 6 months and over who require a thickener for reflux, GORD, dysphagia II. Infants and children already on a thickener for the management of reflux, GORD and dysphagia III. Parents to avoid introducing new weaning/ new foods (for the older infants) whilst on the thickener for 1 week when measuring GI tolerance and thickener intake IV. Willingly given, written, informed consent from patient or parent/guardian

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. Allergy to milk (thickener is made in a factory that handles milk) IV. Children under the age of 6 months of age V. Emergencies VI. Participation in another interventional study

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Treatment and study plan

Resource Thicken up Junior

Dietary Supplement

Each infant and child will be switch over to receive for a period of 7 days (new thickener)

Primary outcomes

  1. Gastrointestinal tolerance

    Time frame: 7 days

    Measure using daily diary

Secondary outcomes

  1. Participant compliance

    Time frame: 7 days

    Daily intake using diary

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance) of a Thickener

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Nov 6, 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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