Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Purna Kashyap, M.B.B.S.

Closed for enrollment

Contact information:

Heather Lekatz

(507)538-1206

Lekatz.Heather@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available