ClinicalTrials.gg
Enrolling by invitationNCT06657001EMPOWERUpdated Jun 12, 2026

Enabling Microbiomics- Driven Personalized Nutrition

An observational study in Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS) and Celiac Disease, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,001
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • GI Disorders
  • Microbiomics
  • Diet
  • Microbiome
  • Nutrition
  • GI Function
03

In context

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.

This study's planned enrollment of 4,001 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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,
  • Participant has a smartphone device with access to internet connection

Exclusion criteria

Exclusion Criteria:

  • Patients with cognitive impairment
  • Active use of antibiotics at the time of stool collection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,001 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • GI Disorders

    Inflammatory Bowel Disease, Irritable Bowel Syndrome, Crohn's Disease, Celiac Disease, Diarrhea, Constipation

06

What researchers measure

Primary outcomes

  1. To Correlate Differences in Diet and Microbiome with Different GI Symptoms and Disease States

    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.

    Time frame: From enrollment through study completion, an average of 1 year.

07

Study locations

1 site
08

References and documents

Publications

  • Asnicar F, Berry SE, Valdes AM, Nguyen LH, Piccinno G, Drew DA, Leeming E, Gibson R, Le Roy C, Khatib HA, Francis L, Mazidi M, Mompeo O, Valles-Colomer M, Tett A, Beghini F, Dubois L, Bazzani D, Thomas AM, Mirzayi C, Khleborodova A, Oh S, Hine R, Bonnett C, Capdevila J, Danzanvilliers S, Giordano F, Geistlinger L, Waldron L, Davies R, Hadjigeorgiou G, Wolf J, Ordovas JM, Gardner C, Franks PW, Chan AT, Huttenhower C, Spector TD, Segata N. Microbiome connections with host metabolism and habitual diet from 1,098 deeply phenotyped individuals. Nat Med. 2021 Feb;27(2):321-332. doi: 10.1038/s41591-020-01183-8. Epub 2021 Jan 11. PubMed 33432175 ↗
  • Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. PubMed 26590418 ↗
  • Thaiss CA, Itav S, Rothschild D, Meijer MT, Levy M, Moresi C, Dohnalova L, Braverman S, Rozin S, Malitsky S, Dori-Bachash M, Kuperman Y, Biton I, Gertler A, Harmelin A, Shapiro H, Halpern Z, Aharoni A, Segal E, Elinav E. Persistent microbiome alterations modulate the rate of post-dieting weight regain. Nature. 2016 Dec 22;540(7634):544-551. doi: 10.1038/nature20796. Epub 2016 Nov 24. PubMed 27906159 ↗
  • Sudharsan B, Peeples M, Shomali M. Hypoglycemia prediction using machine learning models for patients with type 2 diabetes. J Diabetes Sci Technol. 2015 Jan;9(1):86-90. doi: 10.1177/1932296814554260. Epub 2014 Oct 14. PubMed 25316712 ↗
  • Fallaize R, Macready AL, Butler LT, Ellis JA, Lovegrove JA. An insight into the public acceptance of nutrigenomic-based personalised nutrition. Nutr Res Rev. 2013 Jun;26(1):39-48. doi: 10.1017/S0954422413000024. Epub 2013 Apr 8. PubMed 23561449 ↗
  • Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11. PubMed 32528151 ↗
  • Albers DJ, Levine M, Gluckman B, Ginsberg H, Hripcsak G, Mamykina L. Personalized glucose forecasting for type 2 diabetes using data assimilation. PLoS Comput Biol. 2017 Apr 27;13(4):e1005232. doi: 10.1371/journal.pcbi.1005232. eCollection 2017 Apr. PubMed 28448498 ↗
  • Murayama S, Numaguchi Y, Robinson AE, Richardson DE. Magnetic resonance imaging of calvarial eosinophilic granuloma. J Comput Tomogr. 1988 Oct;12(4):251-2. doi: 10.1016/0149-936x(88)90078-1. PubMed 3197424 ↗
  • GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4. PubMed 30954305 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06657001
Lead sponsor
Mayo Clinic
Responsible party
Purna C. Kashyap, MBBS (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 24, 2024
Start date
Mar 28, 2025
Primary completion
Sep 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Jun 12, 2026

Study contacts

Purna Kashyap, MBBS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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