Enabling Microbiomics- Driven Personalized Nutrition (EMPOWER)

June 10, 2026 updated by: Purna C. Kashyap, MBBS, Mayo Clinic

Enabling Microbiomics- Driven Personalized Nutrition (EMPOWER)

The goal of this observational research study is to determine how diet contributes to various gastrointestinal related conditions.

The main question investigators aim to answer is:

Are host genetics, diet, and microbiome all important determinants of GI disorders, and how their relative contribution varies among individuals and populations.

Study Overview

Study Type

Observational

Enrollment (Estimated)

4001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults who have consented to the Mayo Clinic Biobank with gastrointestinal disease.

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Gastrointestinal patients with or without genomic sequencing results available for the following cohorts:

    • Inflammatory Bowel Disease (IBD)
    • Irritable Bowel Syndrome (IBS)
    • Crohn's Disease
    • Celiac Disease
    • Diarrhea
    • Constipation
  • Healthy age and sex matched controls with or without genomic sequencing results available

    o Control is defined as patients without gastrointestinal disease or no symptoms at time of sampling

  • Able to provide written, informed consent
  • Participant has a smartphone device with access to internet connection

Exclusion Criteria:

  • Patients with cognitive impairment
  • Active use of antibiotics at the time of stool collection

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

Cohorts and Interventions

Group / Cohort
GI Disorders
Inflammatory Bowel Disease, Irritable Bowel Syndrome, Crohn's Disease, Celiac Disease, Diarrhea, Constipation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Correlate Differences in Diet and Microbiome with Different GI Symptoms and Disease States
Time Frame: From enrollment through study completion, an average of 1 year.
Investigators will prospectively follow the clinical course of the patients throughout the duration of the study. Patient health outcomes will be documented from their medical record while the study is actively enrolling or undergoing data analysis.
From enrollment through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Purna Kashyap, MBBS, 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.

General Publications

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)

March 28, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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