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Clinical Trials/NCT06657001
NCT06657001
Enrolling By Invitation
Not Applicable

Enabling Microbiomics- Driven Personalized Nutrition (EMPOWER)

Mayo Clinic1 site in 1 country4,001 target enrollmentMarch 28, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Disease (IBD)
Sponsor
Mayo Clinic
Enrollment
4001
Locations
1
Primary Endpoint
To Correlate Differences in Diet and Microbiome with Different GI Symptoms and Disease States
Status
Enrolling By Invitation
Last Updated
10 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2025
End Date
April 1, 2027
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Purna C. Kashyap, MBBS

Principal Investigator

Mayo Clinic

Eligibility Criteria

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
  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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