RECRUITING

Role of Diet on the Microbiome of the Digestive System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-09-29

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04666727

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* • 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

Inclusion Criteria

Exclusion 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

* • 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

Contacts and Locations

Study Contact

Anusha Thomas, MD

CONTACT

713-563-9600

asthomas1@mdanderson.org

Principal Investigator

Anusha Thomas, MD

PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center, Houston, Texas

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77090

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Anusha Thomas, MD, PRINCIPAL_INVESTIGATOR, MD Anderson Cancer Center, Houston, Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-29

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2020-09-29

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Carcinoma