Status:
RECRUITING
Role of Diet on the Microbiome of the Digestive System
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
45+ years
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 ...
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 a...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
September 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04666727
Start Date
September 29 2020
End Date
January 1 2026
Last Update
November 13 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77090