GI Tolerance and Acceptability of a New Thickener

NCT ID: NCT04104815

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2021-02-05

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.

Detailed Description

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Conditions

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Gastro-intestinal Tolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Thickener

Powder thickener

Group Type EXPERIMENTAL

Experimental Thickener

Intervention Type OTHER

Use to thicken liquids

Interventions

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Experimental Thickener

Use to thicken liquids

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Stevenson

Role: STUDY_CHAIR

Abbott Nutrition

Other Identifiers

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DA26

Identifier Type: -

Identifier Source: org_study_id

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