Actively Recruiting
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
Led by Massachusetts General Hospital · Updated on 2026-06-04
40
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research explores how changing to a more plant-based and less animal-based diet affects factors linked to colorectal cancer risk in people with a history of colorectal adenoma. The study focuses on secondary bile acids, gut microbiota, circulating biomarkers, and gene expression related to colonic bile acid receptors. These factors are important because they may influence the development of colorectal cancer, with previous evidence showing diet and gut metabolites play key roles. Participants will follow a self-regulated dietary plan for four weeks, increasing plant-based foods and reducing animal-based foods. The study includes an initial visit before the intervention, a one-week observation period with food diary entries, a four-week diet intervention guided by phone calls and regular stool and body weight collections, and a final visit after completing the intervention. This single-arm trial does not include a comparison group. Participants will complete lifestyle and nutrition questionnaires and provide blood and stool samples at the initial and final visits. During the study, stool samples and body weight will be collected weekly, and food diaries every two days. Researchers will measure changes in stool metabolomics from baseline to the final visit as the main outcome and will also assess changes in gut microbiome composition. The total study duration for each participant is about five weeks, with ongoing monitoring to evaluate the dietary effects.
CONDITIONS
Brief Title
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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%).
- Able and willing to follow study procedures and instructions.
- Ability to understand and willingness to sign a written informed consent document.
You will not qualify if you...
- Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.).
- Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis.
- Prior diagnosis of gastrointestinal cancer or other cancers with active treatment in last three years (except nonmelanoma skin cancer).
- Known diagnosis of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer.
- Any adenoma not completely removed during previous colonoscopy.
- Known bleeding tendency or history of gastrointestinal bleeding requiring hospitalization.
- Current use of anticoagulant therapies and inability or unwillingness to discontinue.
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
- Regular use of aspirin.
- Use of antibiotics or probiotics.
- Inability or unwillingness to reduce animal-based food intake or provide blood or stool samples.
- Receiving other investigational agents.
- Pregnant or breastfeeding.
- Known positive test for HIV, hepatitis C, or hepatitis B infection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants maintain a food diary every 2 days to establish baseline dietary habits before starting the diet intervention.
1 initial visit (in-person)
Duration - 4 weeks
Participants self-regulate their diet by increasing plant-based foods and decreasing animal-based foods. Study staff provide guidance via phone calls. Participants complete food diaries every 2 days, collect stool samples every 7 days, and report body weight weekly.
Multiple remote contacts and sample collections; 1 in-person final visit
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Andrew T. Chan, MD, MPH
K
Kai Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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