DysphagiaNCT01053286
Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin
An observational study of Dysphagia and Gastroesophageal Reflux, run by University of California, Davis at 1 site in United States.
Trial summary
This is a research study to learn more about whether capsaicin, a natural ingredient of chili peppers that makes them taste "hot", can improve swallowing function. The purpose of this study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat enough to improve swallowing function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Gastroesophageal Reflux
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Otolaryngology clinic
Who may be able to join
- Patients older than 18 years of age
- Patients with the following condition: dysphagia, globus, gastroesophageal reflux, neurological disease affecting swallowing or any other condition requiring dynamic swallow study
- Patients willing to provide written informed consent for their participation in the study
Who cannot join
- Patients unable to complete a full dynamic swallow study protocol
- Patients enrolled in another investigational clinical trial that interferes with any testing or testing results
- Patients who are pregnant
- Patients with known sensitivities or allergies to capsaicin or peppers, or nightshades (tomato, bell pepper, eggplant) or latex
- Patients who are prisoners
- Patients who are unable to keep a capsaicin lozenge in their mouth safely for 5 minutes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
This is a research study to learn more about whether capsaicin, a natural ingredient of chili peppers that makes them taste "hot", can improve swallowing function. The purpose of this study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat enough to improve swallowing function.
Read the detailed description
Swallowing problems are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease through to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.
Treatment is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid entering the airway. A novel approach is to try to improve sensation within the pharynx so that patients can feel substances present and then manipulate them in a more appropriate and safe manner. In this regard capsaicin, a nutritional supplement derived from peppers, has shown a stimulatory effect on sensory nerves and an ability to improve the swallowing reflex (Ebihara et al., 2005). Although studies have shown that capsaicin can improve the swallowing reflex, data regarding improvement in swallowing function is lacking. Using a small dose of capsaicin administered as a lozenge, we hope to stimulate sensation within the pharynx enough to improve physical swallowing measures on a contrast swallow study. This method of application is comfortable, easy and directed to the site of action.
- Conditions
- Dysphagia, Gastroesophageal Reflux
- Keywords
- Dysphagia, Globus, Gastroesophageal reflux
- Medical subject headings
- Deglutition Disorders, Gastroesophageal Reflux, Globus Sensation
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in sensation and swallowing after using oral capsaicin
Pt will undergo a standard protocol for conducting dynamic swallow studies with the use of increasing increments of liquid barium, followed by paste consistency and solid consistency barium items, then large volume and continuous drinking of barium. Pictures are taken in both lateral and anteroposterior views. Patients enrolled in the study will undergo the usual protocol but instead of the straw drinking large volume liquid bolus, they will first receive the capsaicin 0.1mg lozenge then after sucking that for 5 minutes will swallow a second 20cc bolus of liquid contrast agent in lateral view. The lozenge is an FDA approved food nutritional supplement and is available in several forms over-the-counter without a prescription. The capsaicin lozenge we will use will be a 0.1mg lozenge. This is a very small concentration of the supplement. We expect this to take no more than 5 minutes to fully dissolve. They will then finish the protocol (AP views) as usual.
Measured: Outcome measure will be determined during the conduction of the dynamic swallow study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter A Belafsky, MD, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053286
- Sponsor's protocol ID
- 200917225
- Status last verified
- May 2017
- First submitted
- 20 Oct 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin
- ClinicalTrials.gov ID
- NCT01053286
- Acronym / sponsor ID
- 200917225
- Conditions
- Dysphagia, Gastroesophageal Reflux
- Keywords
- Dysphagia, Globus, Gastroesophageal reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Jan 2010 (estimated)
- 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.
This is a research study to learn more about whether capsaicin, a natural ingredient of chili peppers that makes them taste "hot", can improve swallowing function. The purpose of this study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat enough to improve swallowing function.
Detailed description
Swallowing problems are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease through to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.
Treatment is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid entering the airway. A novel approach is to try to improve sensation within the pharynx so that patients can feel substances present and then manipulate them in a more appropriate and safe manner. In this regard capsaicin, a nutritional supplement derived from peppers, has shown a stimulatory effect on sensory nerves and an ability to improve the swallowing reflex (Ebihara et al., 2005). Although studies have shown that capsaicin can improve the swallowing reflex, data regarding improvement in swallowing function is lacking. Using a small dose of capsaicin administered as a lozenge, we hope to stimulate sensation within the pharynx enough to improve physical swallowing measures on a contrast swallow study. This method of application is comfortable, easy and directed to the site of action.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Otolaryngology clinic
Key inclusion criteria (3 listed)
- Patients older than 18 years of age
- Patients with the following condition: dysphagia, globus, gastroesophageal reflux, neurological disease affecting swallowing or any other condition requiring dynamic swallow study
- Patients willing to provide written informed consent for their participation in the study
Key exclusion criteria (6 listed)
- Patients unable to complete a full dynamic swallow study protocol
- Patients enrolled in another investigational clinical trial that interferes with any testing or testing results
- Patients who are pregnant
- Patients with known sensitivities or allergies to capsaicin or peppers, or nightshades (tomato, bell pepper, eggplant) or latex
- Patients who are prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in sensation and swallowing after using oral capsaicin
Time frame: Outcome measure will be determined during the conduction of the dynamic swallow study
Pt will undergo a standard protocol for conducting dynamic swallow studies with the use of increasing increments of liquid barium, followed by paste consistency and solid consistency barium items, then large volume and continuous drinking of barium. Pictures are taken in both lateral and anteroposterior views. Patients enrolled in the study will undergo the usual protocol but instead of the straw drinking large volume liquid bolus, they will first receive the capsaicin 0.1mg lozenge then after sucking that for 5 minutes will swallow a second 20cc bolus of liquid contrast agent in lateral view. The lozenge is an FDA approved food nutritional supplement and is available in several forms over-the-counter without a prescription. The capsaicin lozenge we will use will be a 0.1mg lozenge. This is a very small concentration of the supplement. We expect this to take no more than 5 minutes to fully dissolve. They will then finish the protocol (AP views) as usual.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
Peter A Belafsky, MD, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Gastroesophageal Reflux, run by University of California, Davis at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in sensation and swallowing after using oral capsaicin (time frame: Outcome measure will be determined during the conduction of the dynamic swallow study). 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 30 May 2017.