Acceptability and Tolerance Study of a Thickener

Nestlé

Status: Completed

Conditions: Dysphagia

Treatments: Dietary Supplement: Resource Thicken up Junior

Study type: Observational

Funder types: Industry

Identifiers

NCT05026476

RJ1

Details and patient eligibility

About

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

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: No Healthy Volunteers

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