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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07162337
Status
Recruiting
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Conditions

  • Colorectal Adenoma
  • Colorectal Cancer Prevention

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Increased Plant-Based Diet and Decreased Animal-Based Diet — BEHAVIORAL
    Self-regulated diet; increased plant-based foods with decreased animal-based foods

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Increased Plant-Based Diet and Decreased Animal-Based Diet
    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.

Primary Outcome Measure

Change in Stool Metabolomics [ Time Frame: From Baseline to Final Visit (5 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Andrew T. Chan, MD, MPH
[email protected]
617-726-3212
Andrew T. Chan, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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