A Study to Determine if Differences in the Microbe Environment of the Intestines Connects to the Effects of Obesity on Intestinal Stem Cells
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
- Rochester, Minnesota: 16-003158
NCT ID: NCT02863029
Sponsor Protocol Number: 16-003158
About this study
New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The purpose of this study is to find how the microbe envntironment of the intestines in obesity influences the growth of intestinal stem cells, which could then trigger intestinal tumors.
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
- Have a Body Mass Index (BMI) between 20-25 (healthy control) or 35 and above (obese)
- Adults aged 18-65
Exclusion Criteria
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus
- Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them)
- Bowel preparation for colonoscopy within the past week
- Significant bowel surgery other than hysterectomy or appendectomy
- Pregnancy or plans to become pregnant within the study time frame
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
- Age < 18 or vulnerable adults
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Purna Kashyap, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available