Clinical trial NCT04666727: Role of Diet on the Microbiome of the Digestive System
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for a screening colonoscopy at MD Anderson West Houston

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dietary patterns
timeFrame: Baseline
measure: Microbiome composition
timeFrame: Baseline
measure: Somatic mutation burden
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson Cancer Center, Houston, Texas
name: Anusha Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: