RecruitingNCT04666727

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

Sep 29, 2020

Study Type

OBSERVATIONAL

Conditions

Colorectal Carcinoma

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.

Eligibility

Min Age: 45 Years

Inclusion Criteria10

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 Criteria10

• 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