Role of Diet on the Microbiome of the Digestive System

Colorectal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04666727
• Other study ID #: 2019-1148
• Status: Recruiting
• Start date: September 29, 2020
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Anusha Thomas, MD
• Phone: 713-563-9600
• Email: asthomas1[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary patterns	Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.	Baseline
Primary	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.	Baseline
Primary	Somatic mutation burden	Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.	Baseline

External Links

•   MD Anderson Cancer Center Website