NCT06248788

Brief 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. This instrument is available for consumers to purchase and test their own sIgA at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

January 30, 2024

Last Update Submit

February 6, 2024

Conditions

Salivary Immunity

Keywords

salivary immunoglobulin Apoint of care device

Outcome Measures

Primary Outcomes (1)

  • Salivary IgA

    0 minute

Interventions

PoC DeviceDEVICE

PoC Device for Testing Salivary IgA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

any adults that are free from oral infections or oral diseases

You may qualify if:

  • Adults committed to attend the session and follow the instructions described in Experimental Design will be included.

You may not qualify if:

  • Participant with mouth infection or oral disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4Life Research

Sandy City, Utah, 84070, United States

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 8, 2024

Study Start

June 19, 2017

Primary Completion

January 20, 2018

Study Completion

January 20, 2018

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)