Role of Diet on the Microbiome of the Digestive System

May 7, 2024 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for a screening colonoscopy at MD Anderson West Houston

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary patterns
Time Frame: Baseline
Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.
Baseline
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.
Baseline
Somatic mutation burden
Time Frame: Baseline
Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Anusha Thomas, MD, MD Anderson Cancer Center, Houston, Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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