GI Tolerance and Acceptability of a New Thickener

Gastro-intestinal Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04104815
• Other study ID #: DA26
• Status: Withdrawn
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: February 5, 2021

Study information

• Verified date: March 2021
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastro-intestinal Tolerance

Intervention

Other:
• Experimental Thickener
Use to thicken liquids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight in Kg	Study Day 1 and Study Day 7
Other	Medications	Current medication use	Study Day 1 to Study Day 7
Other	Thickness of drinks prescribed	Current prescription per IDDSI guidelines	Study Day 1 to Study Day 7
Other	Medical aetiology of dysphagia	Current documentation of medical aetiology	Study Day 1 and Study Day 7
Primary	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
Primary	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
Primary	Palatability of Study Product	A 5 point scale in the positive direction	Study Day 1 and Study Day 7
Primary	Product Compliance	Patient thickened fluids consumption records	Study Day 1 to Study Day 7