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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04666727
Other study ID # 2019-1148
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2020
Est. completion date January 1, 2026

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Anusha Thomas, MD
Phone 713-563-9600
Email asthomas1@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.


Description:

PRIMARY OBJECTIVES: 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - GROUP I: Patients presenting for a screening colonoscopy - 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: - • Current smokers (nicotine abuse only) - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dietary patterns Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group. Baseline
Primary Microbiome composition Will obtain estimates of microbiome composition from colonic mucosal biopsies in each group. Microbiome composition will be quantified using 16S profiling will be visualized across samples using stacked bar plots and principal coordinate analysis of the weighted Unifrac distances, and microbiome diversity within each sample will be quantified using the inverse-Simpson index. Baseline
Primary Somatic mutation burden Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group. Baseline
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