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NCT07162337Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
31 Jul 2025
Start date
18 Jun 2026
Primary completion date
18 Jun 2027
Lead sponsor
Massachusetts General Hospital
NCT number
NCT07162337

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 18 Jun 2026 to the primary completion date, 18 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Any adenoma that was not completely removed during previous colonoscopy.
  • Participants who are receiving any other investigational agents.

Other illness

  • Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis.
  • Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
  • 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.
  • 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.
  • Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.

Lab values

  • 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.

Other

  • Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.).
  • 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.
  • Pregnant or breastfeeding.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Massachusetts General Hospital Cancer Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.