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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-03-09

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Flexible Sigmoidoscopy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes