Gastro-intestinal ToleranceNCT04104815
GI Tolerance and Acceptability of a New Thickener
A study testing Experimental Thickener in people with Gastro-intestinal Tolerance, run by Abbott Nutrition.
Trial summary
The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-intestinal Tolerance
- What is being tested?
- Experimental Thickener
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2021to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Study to Evaluate the GI Tolerance and Acceptability of a New Thickener for Dysphagia Patients
The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.
- Conditions
- Gastro-intestinal Tolerance
- Being tested
- Experimental Thickener
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ThickenerOther
Use to thicken liquids
| Study group | Role | What they receive |
|---|---|---|
| Experimental Thickener | Experimental | Powder thickener Receives: Other: Experimental Thickener |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Study Day 7
Palatability of Study Product
A 5 point scale in the positive direction
Measured: Study Day 1 and Study Day 7
Product Compliance
Patient thickened fluids consumption records
Measured: Study Day 1 to Study Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start5 Feb 2021
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Why it stopped: Study Timing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-intestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stevenson, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104815
- Sponsor's protocol ID
- DA26
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the GI Tolerance and Acceptability of a New Thickener for Dysphagia Patients
- ClinicalTrials.gov ID
- NCT04104815
- Acronym / sponsor ID
- DA26
- Conditions
- Gastro-intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Timing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Thickener | Experimental | Other: Experimental ThickenerPowder thickener |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental ThickenerUse to thicken liquids | Other | Experimental Thickener |
Primary outcome
Bristol Stool Scale
Time frame: Study Day 1 to Study Day 7
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.
HCP Product Satisfaction Questionnaire
Time frame: Study Day 7
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.
Palatability of Study Product
Time frame: Study Day 1 and Study Day 7
A 5 point scale in the positive direction
Product Compliance
Time frame: Study Day 1 to Study Day 7
Patient thickened fluids consumption records
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Stevenson study chair
Abbott Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Thickener in people with Gastro-intestinal Tolerance, run by Abbott Nutrition.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol Stool Scale (time frame: Study Day 1 to Study Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.