Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 16-006388
NCT ID: NCT03266536
Sponsor Protocol Number: 16-006388
About this study
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
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:
- Adults between (and including) 18-65 years old.
- On a baseline healthy diet characterized by:
- High fiber of ≥ 14 g/1000 calories/day
- < 10% of daily calories from added sugar
- At least 5 servings of fruit and vegetables per day
- < or = 13% of daily calories from saturated fat
Exclusion Criteria:
- Patients who do not meet the above diet requirements.
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
- Presence of abdominal symptoms based on baseline questionnaire.
- Commercial oral antibiotic or probiotic use within the past 4 weeks.
- Pregnancy or plans to become pregnant within the study time frame
- Vulnerable adults
- 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.
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