NCT04203303

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Oct 2019Dec 2030

Study Start

First participant enrolled

October 3, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

11 years

First QC Date

October 11, 2019

Last Update Submit

February 11, 2026

Conditions

Human Microbiota

Outcome Measures

Primary Outcomes (1)

  • Microbiome Differences

    compare the relative abundance of specific microorganism groups

    10 years

Study Arms (1)

Observational

Observational

Other: Observational

Interventions

ObservationalOTHER

Observational

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients who are on the Mayo Clinic campus for clinic appointments or research study visits

You may qualify if:

  • Age 18 years of age or older
  • Able to provide informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Virend Somers, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahid Karim

CONTACT

(507) 422-0763Karim.Shahid@mayo.edu

Nick Wozniak

CONTACT

(507) 255-8794Wozniak.Nicholas@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2019

First Posted

December 18, 2019

Study Start

October 3, 2019

Primary Completion (Estimated)

October 15, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)