Status:
COMPLETED
Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Colorado State University
Conditions:
Small Intestine Bacteria
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
Detailed Description
The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03266536
Start Date
January 9 2017
End Date
May 19 2017
Last Update
May 4 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905