M D Anderson Cancer Center
Houston, Texas, 77090, United States
Location status: Recruiting
NCT Number: NCT04666727
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.
Interested in participating?
Request Info45 year and older
All sexes
Observational
Houston, Texas, 77090, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.
Time frame: Baseline
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.
Time frame: Baseline
Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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