Implications of the Human Microbiota for Health and Disease | NCT04203303

Studies
Implications of the Human Microbiota for Health and Disease

NCT04203303

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Feb 13, 2026Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Human Microbiota

Interventions

Observational

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

Feb 2026

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

Oct 3, 2019Actual

Primary Completion Date

Oct 15, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Dec 17, 2019

First Posted Date

Dec 18, 2019Actual

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

Feb 11, 2026

Last Update Posted Date

Feb 13, 2026Actual

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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Observational	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observational	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microbiome Differences	compare the relative abundance of specific microorganism groups	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shahid Karim	Contact	(507) 422-0763		Karim.Shahid@mayo.edu
Nick Wozniak	Contact	(507) 255-8794		Wozniak.Nicholas@mayo.edu

Overall Officials

Name	Affiliation	Role
Virend Somers, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided