Collection and Analyses of Physiological, Physical, and M... | NCT06381232

Studies
Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population

NCT06381232

Sponsor

Viome

Status

Recruiting

Last Update Posted

Apr 24, 2024Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

General Health
Wellness

Interventions

No Intervention

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2018Actual

Primary Completion Date

Jul 23, 2028Estimated

Completion Date

Jul 23, 2028Estimated

First Submitted Date

Apr 18, 2024

First Submission Date that Met QC Criteria

Apr 18, 2024

First Posted Date

Apr 24, 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

Apr 18, 2024

Last Update Posted Date

Apr 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease.

Detailed Description

The analyses conducted by Viome will include, but are not limited to: genetic, transcriptomic, metabolomic, physiological, and physical. The samples collected from participants may include any of these: stool, blood, saliva, cheek swab, vaginal, breast milk/colostrum, nasal swabs or washes, and urine.

Study participants will collect the clinical samples and ship them to Viome labs or CROs (Contract Research Organizations), where they will be analyzed.

The objective of the study is to establish which foods correspond with increased wellness, and which foods correspond to decreased wellness.

The study hypothesis is that by monitoring the patterns of food intake and lifestyle parameters, in conjunction with non-invasive sample testing, personalized diet and lifestyle recommendations can be elucidated.

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

20,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Control			Other: No Intervention
Cases (Various Phenotypes)			Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	This is an observational study, there are no interventions.	Cases (Various Phenotypes) Healthy Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Molecular Determinants of Health and Disease	We measure thousands of transcript levels in multiple clinical samples. The primary outcome measures are changes in quantitative gene expression, microbial or human, as a result of transitioning from a healthy state to a disease.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anyone that resides in the US at the time of enrollment.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants with specific phenotypes of interest and matched healthy controls.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Momchilo Vuyisich, PhD	Contact	(425) 300-6933		studies@viome.com

Overall Officials

Name	Affiliation	Role
Momchilo Vuyisich, PhD	Viome	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Viome Life Sciences	Recruiting	Bothell	Washington	98011	United States