BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention

NCT07162337 | Not Yet Recruiting DMC

• 1 other identifier: 25-611
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Prevention; Colorectal Adenoma

Keywords

colorectal cancer; colorectal cancer prevention; colorectal adenoma; obesity; western diet

Outcome Measures

Primary Outcomes (1)

• Change in Stool Metabolomics

  Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.

  From Baseline to Final Visit (5 weeks)

Secondary Outcomes (1)

• Relative Composition of Gut Microbiome

  From Baseline to Final Visit (5 weeks)

Other Outcomes (3)

• Change in Plasma Bile Acid Metabolomics

  From Baseline to Final Visit (5 weeks)

• Relative Composition of Circulating Biomarkers

  From Baseline to Final Visit (5 weeks)

• Relative Composition of Circulating Gene Expression Profile

  From Baseline to Final Visit (5 weeks)

Study Arms (1)

Increased Plant-Based Diet and Decreased Animal-Based Diet

EXPERIMENTAL

Participants will be instructed to self-regulate their diet by increasing the amount of plant-based foods while decreasing the amount of animal-based foods for a 4-week period.

Behavioral: Increased Plant-Based Diet and Decreased Animal-Based Diet

Interventions

Increased Plant-Based Diet and Decreased Animal-Based Diet BEHAVIORAL

Self-regulated diet; increased plant-based foods with decreased animal-based foods

Increased Plant-Based Diet and Decreased Animal-Based Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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%).
• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew T. Chan, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew T. Chan, MD, MPH

CONTACT

617-726-3212; achan@mgh.harv

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 9, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the MGB Innovation at PHSINNOVATIONSUPPORT@partners.org

Locations

US (1)