GI Tolerance and Acceptability of a New Thickener | NCT04104815

Studies
GI Tolerance and Acceptability of a New Thickener

NCT04104815

Sponsor

Abbott Nutrition

Status

Withdrawn

Last Update Posted

Mar 17, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Gastro-intestinal Tolerance

Interventions

Experimental Thickener

Countries

Not provided

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study Timing

Expanded Access Info

Start Date

Feb 5, 2021Actual

Primary Completion Date

Feb 5, 2021Actual

Completion Date

Feb 5, 2021Actual

First Submitted Date

Sep 24, 2019

First Submission Date that Met QC Criteria

Sep 24, 2019

First Posted Date

Sep 26, 2019Actual

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

Mar 14, 2021

Last Update Posted Date

Mar 17, 2021Actual

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

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Experimental Thickener	Experimental	Powder thickener	Other: Experimental Thickener

Name	Type	Description	Arm Group Labels	Other Names
Experimental Thickener	Other	Use to thicken liquids	Experimental Thickener

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bristol Stool Scale	The Bristol Stool Scale is used to describe the consistency of stools. Numbers 1-7 are assigned to stools based on descriptions on the scale from hard to liquid.	Study Day 1 to Study Day 7
HCP Product Satisfaction Questionnaire	5 Questions; 3 of the questions utilize a 5 point scale in the positive direction; 2 of the questions are closed categories yes or no.	Study Day 7
Palatability of Study Product	A 5 point scale in the positive direction	Study Day 1 and Study Day 7
Product Compliance	Patient thickened fluids consumption records	Study Day 1 to Study Day 7

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Weight	Weight in Kg	Study Day 1 and Study Day 7
Medications	Current medication use	Study Day 1 to Study Day 7

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has voluntarily signed and dated an ICF approved by an IRB/IEC, and provided applicable privacy authorization prior to any participation in the study.
Subject is diagnosed with dysphagia.
Subject is under the care of a Speech and Language Therapist and is currently using a thickener.
Subject currently has normal GI function.
Subject is interested in participating in the study, willing to comply with the study protocol and product.
Subject who is able to consent and is able to evaluate the product.

Exclusion Criteria:

Subject has a normal swallow.
Subject at high risk of aspiration with oral fluids requiring nil by mouth and enteral tube feeding.
Subject has impaired renal function.
Subject has liver failure, decompensated chronic liver disease, active hepatitis B or C receiving treatment, or hepatic encephalopathy.
Subject has severe dementia or unable to communicate or consent or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
Participant is known to be allergic or intolerant to any ingredient found in the study product.
Participation in another study that has not been approved as a concomitant study.
Subject has a clinical condition that is contraindicated with this product such as hepatic and renal disease.
Subject has a clinical condition which may interfere with gastrointestinal tolerance.
Subject is pregnant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided