Gastro-intestinal Tolerance
Conditions
Brief summary
The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.
Interventions
OTHERExperimental Thickener
Use to thicken liquids
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Compliance | Study Day 1 to Study Day 7 | Patient thickened fluids consumption records |
| Palatability of Study Product | Study Day 1 and Study Day 7 | A 5 point scale in the positive direction |
| Bristol Stool Scale | Study Day 1 to Study Day 7 | 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. |
| HCP Product Satisfaction Questionnaire | Study Day 7 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight | Study Day 1 and Study Day 7 | Weight in Kg |
| Medications | Study Day 1 to Study Day 7 | Current medication use |
| Thickness of drinks prescribed | Study Day 1 to Study Day 7 | Current prescription per IDDSI guidelines |
| Medical aetiology of dysphagia | Study Day 1 and Study Day 7 | Current documentation of medical aetiology |
Outcome results
None listed