Enabling Microbiomics- Driven Personalized Nutrition

• Conditions: Inflammatory Bowel Disease (IBD); Irritable Bowel Syndrome (IBS); Celiac Disease; Diarrhea; Constipation; Microbiome; Crohn's Disease; UC - Ulcerative Colitis; Microscopic Colitis; Functional Dyspepsia

• Registration Number: NCT06657001
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-09
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4001

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Correlate Differences in Diet and Microbiome with Different GI Symptoms and Disease States	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States