GI Tolerance and Acceptability of a New Thickener

A Study to Evaluate the GI Tolerance and Acceptability of a New Thickener for Dysphagia Patients

The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.

Study Overview

• Status: Withdrawn
• Conditions: Gastro-intestinal Tolerance
• Intervention / Treatment: Other: Experimental Thickener

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Thickener; Powder thickener	Other: Experimental Thickener; Use to thicken liquids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
Thickness of drinks prescribed	Current prescription per IDDSI guidelines	Study Day 1 to Study Day 7
Medical aetiology of dysphagia	Current documentation of medical aetiology	Study Day 1 and Study Day 7

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Rebecca Stevenson, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 14, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DA26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No