Role of Diet on the Microbiome of the Digestive System

NCT04666727 | Recruiting

• 1 other identifier: 2019-1148
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (3)

• Dietary patterns

  Will obtain estimates of dietary patterns from colonic mucosal biopsies in each group.

  Baseline

• 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.

  Baseline

• Somatic mutation burden

  Will obtain estimates of somatic mutation burden from colonic mucosal biopsies in each group.

  Baseline

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for a screening colonoscopy at MD Anderson West Houston

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77090, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Stool, blood, tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anusha Thomas, MD

  MD Anderson Cancer Center, Houston, Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anusha Thomas, MD

CONTACT

713-563-9600; asthomas1@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: September 29, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)