Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Diet on the Microbiome of the Digestive System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04666727
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Colorectal Carcinoma

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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
Actual Study Start Date : September 29, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dietary patterns [ Time Frame: Baseline ]
    Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.

  2. 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.

  3. Somatic mutation burden [ Time Frame: Baseline ]
    Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.


Biospecimen Retention:   Samples With DNA
Stool, blood, tissue

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting for a screening colonoscopy at MD Anderson West Houston
Criteria

Inclusion Criteria:

  • GROUP I: Patients presenting for a screening colonoscopy

    • GROUP I: Age of 50 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 50 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 samples

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666727


Contacts
Layout table for location contacts
Contact: Anusha Thomas, MD 713-563-9600 asthomas1@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77090
Contact: Anusha Thomas, MD    713-563-9600    asthomas1@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Anusha Thomas, MD MD Anderson Cancer Center, Houston, Texas
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04666727    
Other Study ID Numbers: 2019-1148
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases