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NCT05026476 Clinical Trial

Acceptability and Tolerance Study of a Thickener

Dysphagia Clinical Trial

Official title:
Evaluation of the Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Thickener

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05026476
Other study ID # RJ1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 16, 2021
Est. completion date March 1, 2023

Study information
Verified date March 2023
Source Société des Produits Nestlé (SPN)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Months to 10 Years
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Resource Thicken up Junior
Each infant and child will be switch over to receive for a period of 7 days (new thickener)

Locations
Country Name City State
United Kingdom Chelsea and Westminster Hospital Foundation Trust London

Sponsors (1)
Lead Sponsor Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastrointestinal tolerance Measure using daily diary 7 days
Secondary Participant compliance Daily intake using diary 7 days
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