Acceptability and Tolerance Study of a Thickener | NCT05026476

Studies
Acceptability and Tolerance Study of a Thickener

NCT05026476

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 6, 2024Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Dysphagia

Interventions

Resource Thicken up Junior

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2021Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Aug 24, 2021

First Submission Date that Met QC Criteria

Aug 24, 2021

First Posted Date

Aug 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2024

Last Update Posted Date

Nov 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resource Thicken up Junior	Dietary Supplement	Each infant and child will be switch over to receive for a period of 7 days (new thickener)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

10 Years

Standard Ages

Child

Study Population

infants and children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Analou Sugar	Chelsea and Westminster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chelsea and Westminster Hospital Foundation Trust		London		SW10 9NH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided