NCT07162337 · Massachusetts General Hospital
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
(BILMOD)
What this study is about
This research study is a forward-looking, single-treatment group$1 clinical trial to assess the effect of a dietary intervention for more plant-based and less animal-based food intake on secondary bile acid production, gut microbiota, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer.
View original scientific description
This research study is a prospective, single-arm clinical trial to assess the effect of a dietary intervention for more plant-based and less animal-based food intake on secondary bile acid production, gut microbiota, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations