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Prevention study for Colorectal Cancer Prevention
Official title BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
ClinicalTrials.gov ID: NCT07162337
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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%).
You likely can't join if
- 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...
- 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...
See the full eligibility 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%).
- people must be able and willing to follow study procedures and instructions.
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.