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NCT04666727 | RECRUITING | Colorectal Carcinoma

Role of Diet on the Microbiome of the Digestive System
Sponsor:

M.D. Anderson Cancer Center

Brief 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.

Condition or disease

Colorectal Carcinoma

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 30 participants
Official Title : The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study
Actual Study Start Date : 2020-09-29
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2026-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Role of Diet on the Microbiome of the Digestive System

Location Details

NCT04666727

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How to Participate

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77090