Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | January 2017 |
| End Date: | October 2021 |
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
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
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.
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.
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 -
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