- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203303
Implications of the Human Microbiota for Health and Disease
February 11, 2026 updated by: Virend Somers, MD, PhD, Mayo Clinic
The purpose of this study is to advance the understanding of human health and disease as it relates to environmental factors that may affect intestinal and non-intestinal microbiota.
Study Overview
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shahid Karim
- Phone Number: (507) 422-0763
- Email: Karim.Shahid@mayo.edu
Study Contact Backup
- Name: Nick Wozniak
- Phone Number: (507) 255-8794
- Email: Wozniak.Nicholas@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Principal Investigator:
- Virend Somers, MD
-
Contact:
- Nick Wozniak
- Phone Number: (507) 255-8794
- Email: Wozniak.Nicholas@mayo.edu
-
Contact:
- Shahid Karim
- Phone Number: 507-422-0763
- Email: Karim.Shahid@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Eligible patients who are on the Mayo Clinic campus for clinic appointments or research study visits
Description
Inclusion Criteria:
- Age 18 years of age or older
- Able to provide informed consent
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
|
Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiome Differences
Time Frame: 10 years
|
compare the relative abundance of specific microorganism groups
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Virend Somers, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2019
Primary Completion (Estimated)
October 15, 2030
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (Actual)
December 18, 2019
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 11, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-001234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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