Acceptability and Tolerance Study of a Thickener
- Conditions
- Dysphagia
- Registration Number
- NCT05026476
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastrointestinal tolerance 7 days Measure using daily diary
- Secondary Outcome Measures
Name Time Method Participant compliance 7 days Daily intake using diary
Trial Locations
- Locations (1)
Chelsea and Westminster Hospital Foundation Trust
🇬🇧London, United Kingdom