GI Tolerance and Acceptability of a New Thickener

NCT04104815 | Withdrawn

• 1 other identifier: DA26
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastro-intestinal Tolerance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Weight

  Study Day 1 and Study Day 7

• Medications

  Study Day 1 to Study Day 7

• Thickness of drinks prescribed

  Study Day 1 to Study Day 7

Study Arms (1)

Experimental Thickener

EXPERIMENTAL

Powder thickener

Other: Experimental Thickener

Interventions

Experimental Thickener OTHER

Use to thicken liquids

Experimental Thickener

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Officials

• Rebecca Stevenson

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: February 5, 2021
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share