Inflammatory Bowel Disease (IBD)EMPOWERNCT06657001
Enabling Microbiomics- Driven Personalized Nutrition
An observational study of Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS), run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease
- How many people
- 4,001 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2025to Apr 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have consented to the Mayo Clinic Biobank with gastrointestinal disease.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Patients with cognitive impairment
- Active use of antibiotics at the time of stool collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Diarrhea, Constipation, Microbiome
- Keywords
- GI Disorders, Microbiomics, Diet, Microbiome, Nutrition, GI Function
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Celiac Disease, Diarrhea, Constipation, Crohn Disease, Colitis, Ulcerative, Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GI Disorders | Inflammatory Bowel Disease, Irritable Bowel Syndrome, Crohn's Disease, Celiac Disease, Diarrhea, Constipation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start28 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,001 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna Kashyap, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657001
- Sponsor's protocol ID
- 24-007049
- Acronym
- EMPOWER
- Status last verified
- Jun 2026
- First submitted
- 22 Oct 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33432175Zeevi 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 26590418Thaiss 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 27906159Sudharsan 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 25316712Fallaize 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 23561449Berry 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 32528151Albers 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 28448498Murayama 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 3197424GBD 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Microbiomics- Driven Personalized Nutrition (EMPOWER)
- ClinicalTrials.gov ID
- NCT06657001
- Acronym / sponsor ID
- EMPOWER / 24-007049
- Conditions
- Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Diarrhea, Constipation, Microbiome
- Keywords
- GI Disorders, Microbiomics, Diet, Microbiome, Nutrition, GI Function
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,001 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GI Disorders | – | –Inflammatory Bowel Disease, Irritable Bowel Syndrome, Crohn's Disease, Celiac Disease, Diarrhea, Constipation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have consented to the Mayo Clinic Biobank with gastrointestinal disease.
Key inclusion criteria (12 listed)
- Age greater than or equal to 18 years
- Gastrointestinal patients with or without genomic sequencing results available for the following cohorts:
- 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
Key exclusion criteria (2 listed)
- Patients with cognitive impairment
- Active use of antibiotics at the time of stool collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 33432175Asnicar 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.
- Background: PubMed 26590418Zeevi 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.
- Background: PubMed 27906159Thaiss 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.
- Background: PubMed 25316712Sudharsan 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.
- Background: PubMed 23561449Fallaize 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.
- Background: PubMed 32528151Berry 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.
- Background: PubMed 28448498Albers 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.
- Background: PubMed 3197424Murayama 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.
- Background: PubMed 30954305GBD 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Purna Kashyap, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657001, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.