A Study Of Evaluating The Healthy Microbiome
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-009531
About this study
The purpose of this study is to collect and maintain coded, one-time stool specimens and limited clinical characteristics from adults without known liver disease for use as control samples in microbiome laboratory research.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
General Inclusion Criteria:
Age 18 years or older.
Able to provide informed consent and privacy authorization.
Positive Mayo Clinic research authorization at the time of recruitment.
Able and willing to collect stool at home on one occasion, place the specimen into the four study tubes, and return the kit according to instructions.
No known liver disease.
Meets criteria for either the Healthy Control group or the Matched Control group
Healthy Control Criteria:
BMI from 18.5 through 25.0 kg/m2 at screening.
No current medication use. The screening guide will define whether vitamins, supplements, hormonal contraception, topical agents, and occasional as-needed medications count as current medications.
Matched Control Criteria:
No known liver disease.
Meets the prespecified matching criteria for older age and metabolic comorbidities relative to a liver-disease participant or cohort.
Medication use is permitted and will be recorded; there are no medication restrictions for this group.
Exclusion Criteria:
Unable or unwilling to provide informed consent and privacy authorization.
Unable to complete the at-home stool collection or return the kit.
Known liver disease.
Does not meet the criteria for either study group.
Previously provided a stool specimen under this protocol, unless repeat participation is later approved by amendment
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 08/10/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Patricia Bloom, M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available