CClinicalTrials.gg
WithdrawnNCT04104815Updated Mar 17, 2021

GI Tolerance and Acceptability of a New Thickener

An interventional study of Experimental Thickener in Gastro-intestinal Tolerance, sponsored by Abbott Nutrition. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Why this study was withdrawn
Study Timing
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Gastro-intestinal Tolerance
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental Thickener

    Powder thickener

    Other: Experimental Thickener

Interventions

  • OtherExperimental Thickener

    Use to thicken liquids

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Study Day 1 to Study Day 7

  2. 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.

    Time frame: Study Day 7

  3. Palatability of Study Product

    A 5 point scale in the positive direction

    Time frame: Study Day 1 and Study Day 7

  4. Product Compliance

    Patient thickened fluids consumption records

    Time frame: Study Day 1 to Study Day 7

Other outcomes

  1. Weight

    Weight in Kg

    Time frame: Study Day 1 and Study Day 7

  2. Medications

    Current medication use

    Time frame: Study Day 1 to Study Day 7

  3. Thickness of drinks prescribed

    Current prescription per IDDSI guidelines

    Time frame: Study Day 1 to Study Day 7

  4. Medical aetiology of dysphagia

    Current documentation of medical aetiology

    Time frame: Study Day 1 and Study Day 7

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04104815
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Feb 5, 2021
Primary completion
Feb 5, 2021
Completion
Feb 5, 2021
Last update
Mar 17, 2021

Study contacts

Rebecca Stevenson
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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