Yükleniyor... / Loading...
This study examines changes in the bile acid-gut microbiome axis through increasing plant-based eating and reducing animal-based eating, aiming to help prevent colorectal cancer. Individuals aged 18 to 80 who habitually eat a Western diet and have had at least one adenoma (polyp) removed during colonoscopy may take part. This is a study without a clinical phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.