Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
4001 participants
OBSERVATIONAL
2025-03-28
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GI Disorders
Inflammatory Bowel Disease, Irritable Bowel Syndrome, Crohn's Disease, Celiac Disease, Diarrhea, Constipation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Active use of antibiotics at the time of stool collection
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Purna C. Kashyap, MBBS
Principal Investigator
Principal Investigators
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Purna Kashyap, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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24-007049
Identifier Type: -
Identifier Source: org_study_id
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