Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells

February 17, 2022 updated by: Purna C. Kashyap, MBBS, Mayo Clinic

New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors.

The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants from each of two different BMI categories: 20-25 and 35 & above), who will be asked to provide blood, stool, & urine samples, undergo a flexible sigmoidoscopy, and complete food frequency questionnaires

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

The investigators will test the hypothesis that the gut microbiome drives many of the effects that a pro-obesity high-fat diet has on intestinal stem cell (ISC) biology, which includes 1) an increase in ISC numbers and proliferation, 2) a reduced dependency on niche cells for intestinal organoid initiation, or 3) the acquisition of organoid-initiation by non-stem cell population in the intestinal epithelium.

Specific Aims:

  1. To determine whether differences in the gut microbiome in obese human subjects correlates with enhanced intestinal stem cell numbers and function.
  2. To validate whether obesity-driven changes in the gut microbiome of human recapitulate the effects of obesity on intestinal stem cell function in germ-free mice.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Subject and Control Inclusion Criteria

  1. Participants have a Body Mass Index (BMI) between 20-25 or 35 and above.
  2. Adults aged 18-65

Exclusion Criteria:

  1. Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus
  2. Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them)
  3. Bowel preparation for colonoscopy within the past week
  4. Significant bowel surgery other than hysterectomy or appendectomy
  5. Pregnancy or plans to become pregnant within the study time frame
  6. 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.
  7. Age<18 or vulnerable adults -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Flexible Sigmoidoscopy
Participants will undergo an unsedated Flexible Sigmoidoscopy in order to obtain 12 mucosal biopsies. Serum cholesterol, triglyceride and HBA1C levels will be determined. Plasma, serum and whole blood will be stored for future use for next generation sequencing and metabolomics to determine the effect of different genetic loci on composition and function of gut microbiota
Procedure: Flexible Sigmoidoscopy
A sigmoidoscopy is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon, using a flexible endoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the growth of intestinal stem cells
Time Frame: Two years
The gut microbiome is altered in obesity and studying intestinal stem cells will be helpful in learning what triggers intestinal tumors.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Purna C Kashyap, M., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 9, 2017

Study Completion (Actual)

March 9, 2017

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-003158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Tissue samples will be sent to the Massachusetts Institute of Technology (MIT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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