- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06657001
Enabling Microbiomics- Driven Personalized Nutrition (EMPOWER)
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
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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GI Disorders
Inflammatory Bowel Disease, Irritable Bowel Syndrome, Crohn's Disease, Celiac Disease, Diarrhea, Constipation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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From enrollment through study completion, an average of 1 year.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Purna Kashyap, MBBS, Mayo Clinic
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Signs and Symptoms, Digestive
- Intestinal Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Gastroenteritis
- Malabsorption Syndromes
- Colonic Diseases, Functional
- Colitis
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Irritable Bowel Syndrome
- Digestive System Diseases
- Colitis, Ulcerative
- Crohn Disease
- Constipation
- Inflammatory Bowel Diseases
- Celiac Disease
- Colitis, Microscopic
- Diarrhea
Other Study ID Numbers
- 24-007049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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