- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248788
Salivary Immunoglobulin A (sIgA) Normal Range Study (sIgA)
February 6, 2024 updated by: 4Life Research, LLC
Study to Survey the Normal Range of Salivary Immunoglobulin A (sIgA) Levels Measured by a Point of Care Device in Healthy Adult Women and Men
Salivary Immunoglobulin A (sIgA) is a marker of immune system activity.
Typically, sIgA is determined by an ELISA test in which samples have to be sent to a specialized laboratory for testing.
Investigators have developed a new instrument that is small, portable, and easy to use.
This instrument is available for consumers to purchase and test their own sIgA at home.
Study Overview
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
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Sandy, Utah, United States, 84070
- 4Life Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
any adults that are free from oral infections or oral diseases
Description
Inclusion Criteria:
- Adults committed to attend the session and follow the instructions described in Experimental Design will be included.
Exclusion Criteria:
- Participant with mouth infection or oral disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Salivary IgA
Time Frame: 0 minute
|
0 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2017
Primary Completion (Actual)
January 20, 2018
Study Completion (Actual)
January 20, 2018
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Actual)
February 8, 2024
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- RSC-014-00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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