Diet Education for Colorectal Cancer Prevention

This study is looking at how changing your diet can help prevent colorectal cancer. Researchers are studying if eating more plant-based foods and fewer animal-based foods affects certain substances in your body called bile acids, your gut microbiome (the bacteria in your intestines), and other markers related to colorectal cancer. You may be able to join if you are 18-80 years old, have had at least one colon adenoma (a growth that can become cancerous) removed, usually eat a Western diet, and meet certain weight requirements. The main goal is to see how your stool metabolomics (a measure of substances in your stool) change over 5 weeks.

Study design
This is a single-arm study, meaning all 40 participants will receive the same dietary intervention. The study does not specify a phase.
What's involved
You will follow a self-regulated diet with increased plant-based foods and decreased animal-based foods. Your stool metabolomics will be measured from the start of the study to the final visit, which is 5 weeks later.
Compensation
Not stated in the trial record.
Follow-up
Your stool metabolomics will be measured up to 5 weeks after the start of the study.

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NCT07162337

BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention

Recruiting
NAAges 18–80InterventionalPrevention
Massachusetts General Hospital
~40 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Increased Plant-Based Diet and Decreased Animal-Based Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Stool Metabolomics
Measured over From Baseline to Final Visit (5 weeks)
Colorectal Cancer Prevention
Colorectal Adenoma
1 sites across 1 states
Massachusetts1
  • Andrew T. Chan, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
  • Kai Wang, PhD · STUDY_DIRECTOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

Underwent screening or surveillance colonoscopy with removal of at least one adenoma.
Age 18-80 years.
Habitually consume a Western pattern diet.
BMI of at least 18.5 kg/m2 but less than 35 kg/m2
Weight stable in last 3 months (loss or gain \<4%).
Subjects must be able and willing to follow study procedures and instructions.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.).
Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis.
Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years.
Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
Any adenoma that was not completely removed during previous colonoscopy.
Known bleeding tendency/condition (e.g. von Willebrand disease) or history of peptic ulcer or gastrointestinal bleed requiring hospitalization, endoscopic complications, or contraindication to colonoscopy.
Current use of anticoagulant therapies, including Heparin, Warfarin, Dalteparin sodium, Bivalirudin, Argatroban, Lepirudin, Heparin Sodium, Heparin/Dextrose, and an unwillingness or inability to discontinue anticoagulants.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Regular use of aspirin.
Use of antibiotics or probiotics.
Inability or unwillingness to abstain from limited consumption of animal-based food or to provide blood or stool samples during the study.
Participants who are receiving any other investigational agents.
Pregnant or breastfeeding.
Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
  • Change in Stool MetabolomicsFrom Baseline to Final Visit (5 weeks)

    Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.