Acceptability and Tolerance Study of a Thickener

Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance) 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

Study Overview

• Status: Completed
• Conditions: Dysphagia
• Intervention / Treatment: Dietary supplement: Resource Thicken up Junior

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 10 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

infants and children

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal tolerance	Measure using daily diary	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant compliance	Daily intake using diary	7 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Analou Sugar, Chelsea and Westminster

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: RJ1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No