Role of Diet on the Microbiome of the Digestive System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Carcinoma. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Dietary patterns [Time frame: Baseline]
- Microbiome composition [Time frame: Baseline]
- Somatic mutation burden [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04666727 · 2019-1148