Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
30 participants
OBSERVATIONAL
2020-09-29
2026-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To evaluate the differences in dietary patterns among individuals reporting to be vegetarian and omnivorous.
II. To compare the difference in stool microbiome pattern in the above mentioned two groups of individuals.
III. To compare somatic mutations in colorectal epithelial cells in the above mentioned two groups of individuals.
SECONDARY OBJECTIVE:
I. To identify and characterize an association between diet, the microbiome and its genotoxic effect on the colorectal epithelial cells and predisposition to colorectal carcinogenesis.
OUTLINE:
Participants complete dietary questionnaire over 30-60 minutes and undergo collection of stool, blood, and tissue samples for analysis via sequencing and laser dissection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* GROUP I: Age of 45 and above
* GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)
* GROUP I: Non smoker
* GROUP I: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples
* GROUP II: Patients presenting for a screening colonoscopy
* GROUP II: Age of 45 and above
* GROUP II: Omnivorous diet
* GROUP II: Non smoker
* GROUP II: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample
Exclusion Criteria
* Positive family history of colon cancer or colon cancer related syndromes
* Recent use of antibiotics in 1 month
* History of inflammatory bowel disease, and/or radiation enteritis or colitis
* Pregnant and breastfeeding women
* Women of child-bearing potential who have positive urine or serum pregnancy test
* Heavy drinker (defined as more than 14 drinks per week)
* Currently using anti-flatulence medications, probiotics and/or fiber supplements
* Major dietary restrictions and/or following a special diet
* Patient with positive fecal test/symptoms
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anusha Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center, Houston, Texas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Anusha Thomas, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-1148
Identifier Type: -
Identifier Source: org_study_id