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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The 4-week intervention phase will involve phone calls from study staff to guide participants in their diet changes, additional food diary entries (every 2 days), stool sample collection (every 7 days), and body weight reporting (every 7 days)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

MA