NCT07162337 BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
| NCT ID | NCT07162337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Colorectal Cancer Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-18 |
| Primary Completion | 2027-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-06-18 with a primary completion date of 2027-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, gut microbiota, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer.
Eligibility Criteria
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.
Contact & Investigator
Andrew T. Chan, MD, MPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07162337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07162337 currently recruiting?
Yes, NCT07162337 is actively recruiting participants. Contact the research team at achan@mgh.harvard.edu for enrollment information.
Where is the NCT07162337 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07162337 clinical trial?
NCT07162337 is sponsored by Massachusetts General Hospital. The principal investigator is Andrew T. Chan, MD, MPH at Massachusetts General Hospital. The trial plans to enroll 40 participants.
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