Role of Diet on the Microbiome of the Digestive System
ConditionColorectal Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
• 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
Trial population
Patients presenting for a screening colonoscopy at MD Anderson West Houston
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Dietary patterns
Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.
Time frame
Baseline2
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.
Time frame
Baseline3
Somatic mutation burden
Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov