Colorectal CarcinomaNCT04666727
Role of Diet on the Microbiome of the Digestive System
An observational study of Colorectal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Colorectal Carcinoma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for a screening colonoscopy at MD Anderson West Houston
Who may be able to join
- 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
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- 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
Who cannot join
- • 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77090
Anusha Thomas, MD, 713-563-9600, asthomas1@mdanderson.org
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Colorectal Carcinoma
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary patterns
Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.
Measured: Baseline
Microbiome composition
Will obtain estimates of microbiome composition from colonic mucosal biopsies in each group. Microbiome composition will be quantified using 16S profiling will be visualized across samples using stacked bar plots and principal coordinate analysis of the weighted Unifrac distances, and microbiome diversity within each sample will be quantified using the inverse-Simpson index.
Measured: Baseline
Somatic mutation burden
Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start29 Sep 2020
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anusha Thomas, MD, Principal investigator, MD Anderson Cancer Center, Houston, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666727
- Sponsor's protocol ID
- 2019-1148
- Status last verified
- May 2026
- First submitted
- 8 Dec 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666727
- Acronym / sponsor ID
- 2019-1148
- Conditions
- Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for a screening colonoscopy at MD Anderson West Houston
Key inclusion criteria (10 listed)
- GROUP I: Patients presenting for a screening colonoscopy
Key exclusion criteria (10 listed)
- • Current smokers (nicotine abuse only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dietary patterns
Time frame: Baseline
Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.
Microbiome composition
Time frame: Baseline
Will obtain estimates of microbiome composition from colonic mucosal biopsies in each group. Microbiome composition will be quantified using 16S profiling will be visualized across samples using stacked bar plots and principal coordinate analysis of the weighted Unifrac distances, and microbiome diversity within each sample will be quantified using the inverse-Simpson index.
Somatic mutation burden
Time frame: Baseline
Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anusha Thomas, MD principal investigator
MD Anderson Cancer Center, Houston, Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anusha Thomas, MD (713-563-9600, asthomas1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary patterns (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.