GI Tolerance and Acceptability of a New Thickener

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

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

Conditions
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Gastro-intestinal Tolerance

Intervention / Treatment
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* Other: Experimental Thickener


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Thickener<br>Powder thickener | Other: Experimental Thickener<br>* Use to thicken liquids<br>|

What is the study measuring?
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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 |