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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06381232
Other study ID # VIOME-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 23, 2018
Est. completion date July 23, 2028

Study information

Verified date March 2024
Source Viome
Contact Momchilo Vuyisich, PhD
Phone (425) 300-6933
Email studies@viome.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date July 23, 2028
Est. primary completion date July 23, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Anyone that resides in the US at the time of enrollment. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention
This is an observational study, there are no interventions.

Locations

Country Name City State
United States Viome Life Sciences Bothell Washington

Sponsors (1)

Lead Sponsor Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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