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Role of Diet on the Microbiome of the Digestive System

The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how diet affects bacteria and other tiny living things in the digestive system. Researchers want to learn whether these changes affect how cancer develops in the colon or rectum. It is for adults age 45 or older who are having a screening colonoscopy and eat a strict vegetarian diet or both plant and animal foods.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 45 or older.
  • Having a screening colonoscopy, a test that looks inside the colon for cancer.
  • Eat either a strict vegetarian diet, checked with a diet survey, or both plant and animal foods.
  • Do not smoke.
  • Can understand the study and are willing to sign a consent form.
  • Willing to complete an online diet survey and give stool, colon lining, and blood samples.

Who can't join

  • Currently smoke nicotine products.
  • Have a family history of colon cancer or conditions linked to colon cancer.
  • Used antibiotics within the past month.
  • Have had inflammatory bowel disease or swelling in the intestines caused by radiation treatment.
  • Are pregnant, breastfeeding, or able to become pregnant and have a positive urine or blood pregnancy test.
  • Drink more than 14 alcoholic drinks per week.
  • Currently use gas-relief medicines, probiotics (helpful bacteria), or fiber supplements.
  • Have major food restrictions or follow a special diet, or have a positive stool test or symptoms.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX