NCT04666727

Role of Diet on the Microbiome of the Digestive System

The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colorectal Carcinoma

Timeline

• Start date: 2020-09-29
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-12-14
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States