Acceptability and Tolerance Study of a Thickener

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05026476

Enrollment

Registered

2021-08-30

Start date

2021-08-16

Completion date

2023-03-01

Last updated

2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

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).

Interventions

DIETARY_SUPPLEMENTResource Thicken up Junior

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 10 Years

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Gastrointestinal tolerance	7 days	Measure using daily diary

Secondary

Measure	Time frame	Description
Participant compliance	7 days	Daily intake using diary

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026