BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention (NCT07162337) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
United States40 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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…