Salivary ImmunitysIgANCT06248788
Salivary Immunoglobulin A (sIgA) Normal Range Study
An observational study of Salivary Immunity, run by 4Life Research, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Salivary Immunity
- What is being tested?
- PoC Device
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 20 Jan 2018
- 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: any adults that are free from oral infections or oral diseases
Who may be able to join
- Adults committed to attend the session and follow the instructions described in Experimental Design will be included.
Who cannot join
- Participant with mouth infection or oral disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Salivary Immunity
- Being tested
- PoC Device
- Keywords
- salivary immunoglobulin A, point of care device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoC DeviceDevice
PoC Device for Testing Salivary IgA
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary IgA
Measured: 0 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Jun 2017
- Primary completion20 Jan 2018
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary ImmunityStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Life Research, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248788
- Sponsor's protocol ID
- RSC-014-00
- Acronym
- sIgA
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06248788
- Acronym / sponsor ID
- sIgA / RSC-014-00
- Conditions
- Salivary Immunity
- Keywords
- salivary immunoglobulin A, point of care device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- 4Life Research, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 8 Feb 2024 (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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- any adults that are free from oral infections or oral diseases
Key inclusion criteria (1 listed)
- Adults committed to attend the session and follow the instructions described in Experimental Design will be included.
Key exclusion criteria (1 listed)
- Participant with mouth infection or oral disease
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 |
|---|---|---|
| PoC DevicePoC Device for Testing Salivary IgA | Device | – |
Primary outcome
Salivary IgA
Time frame: 0 minute
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 8 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Salivary Immunity, run by 4Life Research, LLC 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 1 inclusion and 1 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 8 Feb 2024. 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?
Salivary IgA (time frame: 0 minute). 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 8 Feb 2024.