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

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ClinicalTrials.gov Identifier: NCT03266536
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Colorado State University
University of Minnesota - Clinical and Translational Science Institute
Imperial College London
Information provided by (Responsible Party):
Purna C. Kashyap, MBBS, Mayo Clinic

Brief Summary:
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?

Condition or disease Intervention/treatment Phase
Small Intestine Bacteria Behavioral: Western diet Not Applicable

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 (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
No Intervention: No western diet
Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete.
Experimental: Western diet
Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies).
Behavioral: Western diet
Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.




Primary Outcome Measures :
  1. Transcriptional changes in gut microbiota present in stool. [ Time Frame: Baseline, approximately three weeks. ]
    DNA extraction from stool samples will be done using standard assays.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266536


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Icahn School of Medicine at Mount Sinai
Colorado State University
University of Minnesota - Clinical and Translational Science Institute
Imperial College London
Investigators
Principal Investigator: Purna C Kashyap, M.B.B.S. Mayo Clinic

Responsible Party: Purna C. Kashyap, MBBS, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03266536     History of Changes
Other Study ID Numbers: 16-006388
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.

Keywords provided by Purna C. Kashyap, MBBS, Mayo Clinic:
Gut microbiota