Status:
NOT_YET_RECRUITING
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer Prevention
Colorectal Adenoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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,...
Detailed Description
In this research study, the investigators are: * Investigating the effect of more plant-based and less animal-based food intake on bile acid metabolomic composition in stool among individuals with a ...
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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07162337
Start Date
January 1 2026
End Date
February 1 2028
Last Update
November 19 2025
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114