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

Société des Produits Nestlé (SPN)1 site in 1 country21 target enrollmentAugust 16, 2021

ConditionsDysphagia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dysphagia
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 21
Locations: 1
Primary Endpoint: Gastrointestinal tolerance
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

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).

Registry

clinicaltrials.gov

Start Date

August 16, 2021

End Date

March 1, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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