Salivary Immunoglobulin A (sIgA) Normal Range Study | NCT06248788

Studies
Salivary Immunoglobulin A (sIgA) Normal Range Study

NCT06248788

Sponsor

4Life Research, LLC

Status

Completed

Last Update Posted

Feb 8, 2024Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Salivary Immunity

Interventions

PoC Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2017Actual

Primary Completion Date

Jan 20, 2018Actual

Completion Date

Jan 20, 2018Actual

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Name	Type	Description	Arm Group Labels	Other Names
PoC Device	Device	PoC Device for Testing Salivary IgA

Measure	Description	Time Frame
Salivary IgA		0 minute

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

any adults that are free from oral infections or oral diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
4Life Research		Sandy City	Utah	84070	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided