BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Increased Plant-Based Diet and Decreased Animal-Based Diet
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov