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

Mayo Clinic

Status: Completed

Conditions: Small Intestine Bacteria

Treatments: Behavioral: Western diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03266536

16-006388

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

No western diet

No Intervention group

Description:

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.

Western diet

Experimental group

Description:

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).

Treatment:

Behavioral: Western diet