Dysphagia Clinical Trial
Official title:
Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin
Verified date | May 2017 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Outcome measure will be determined during the conduction of the dynamic swallow study |
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