Role of Diet on the Microbiome of the Digestive System

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

45 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 population

Patients presenting for a screening colonoscopy at MD Anderson West Houston

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

M.D. Anderson Cancer Center

Study start

Sep 29, 2020 Actual

Primary completion

Jan 1, 2027 Estimated

Study completion

Jan 1, 2027 Estimated

First posted

Dec 14, 2020 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts