GI Tolerance and Acceptability of a New Thickener

Abbott

Status: Withdrawn

Conditions: Gastro-intestinal Tolerance

Treatments: Other: Experimental Thickener

Study type: Interventional

Funder types: Industry

Identifiers

NCT04104815

DA26

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Experimental Thickener

Experimental group

Description:

Powder thickener

Treatment:

Other: Experimental Thickener