Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04666727

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Colorectal Carcinoma

Study ID

NCT04666727

Start date

Sep 29, 2020

Status verified date

May, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Dietary patterns [ Time Frame: Baseline ]
  • Microbiome composition [ Time Frame: Baseline ]
  • Somatic mutation burden [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Anusha Thomas, MD

713-563-9600asthomas1@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77090

Contacts

Anusha Thomas, MD

713-563-9600asthomas1@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-26.