Analyzing IBS to Identify Biomarkers and Microbiome Signatures
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 14-008799
NCT ID: NCT02419963
Sponsor Protocol Number: 14-008799
About this study
Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion criteria:
- IBS-D subjects:
- Patients who fulfill IBS-D criteria, without causes of active inflammation.
- active symptoms for at least 2 months
- diagnosed at least 6 months prior to enrollment
- Healthy Control:
- Healthy control patients should have no active infection or inflammation.
Exclusion criteria:
- does not meet inclusion criteria
- will not participate in blood draw, stool sample donation, or endoscopy
- history of acute illness within 3 months of testing
- any fecal transplant history
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amy Foxx-Orenstein, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available