NCT04666727Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 8 Dec 2020
- Start date
- 29 Sept 2020
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT04666727
What you commit to
- Study type: Observational
- Planned participants: 30
- From 29 Sept 2020 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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
Who the study is looking for
- 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
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.