Human MicrobiotaNCT04203303
Implications of the Human Microbiota for Health and Disease
An observational study of Human Microbiota, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Microbiota
- What is being tested?
- Observational
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible patients who are on the Mayo Clinic campus for clinic appointments or research study visits
Who may be able to join
- Age 18 years of age or older
- Able to provide informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Shahid Karim, 507-422-0763, Karim.Shahid@mayo.edu
Nick Wozniak, (507) 255-8794, Wozniak.Nicholas@mayo.edu
About this study
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.
- Conditions
- Human Microbiota
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Observational | Observational Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Differences
compare the relative abundance of specific microorganism groups
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start3 Oct 2019
- Primary completion15 Oct 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiotaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203303
- Sponsor's protocol ID
- 19-001234
- Status last verified
- Feb 2026
- First submitted
- 11 Oct 2019
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of the Human Microbiota for Health and Disease
- ClinicalTrials.gov ID
- NCT04203303
- Acronym / sponsor ID
- 19-001234
- Conditions
- Human Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 15 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalObservational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients who are on the Mayo Clinic campus for clinic appointments or research study visits
Key inclusion criteria (2 listed)
- Age 18 years of age or older
- Able to provide informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Observational |
Primary outcome
Microbiome Differences
Time frame: 10 years
compare the relative abundance of specific microorganism groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Human Microbiota
Not yet recruiting
AdHuman - Impact of Food Additives in Humans
Healthy Adult
Not yet recruiting
Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)
Human Papillomavirus Infection, Human Papillomavirus Infections
Not yet recruiting
Whole Food Fibers for Support of Key Gut Bacteria for Human Health
Prediabetes or Overweight
RecruitingPhase 4
Antibiotics and Vaccine Immune Responses Study
Vaccine Response Impaired
RecruitingObservational study
Human Genes and Microbiota in Early Life
Host and Microbiome, Pregnancy Outcomes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virend Somers, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Microbiota, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahid Karim ((507) 422-0763, Karim.Shahid@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Differences (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.