Clinical trial · Interventional
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
BILMOD: BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
NCT07162337CI-TRIAL-00115578BILMODrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Increased Plant-Based Diet and Decreased Animal-Based Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Increased Plant-Based Diet and Decreased Animal-Based Diet
- description
- 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.
- interventionNames
- Behavioral: Increased Plant-Based Diet and Decreased Animal-Based Diet
Primary outcomes (1)
- measure
- Change in Stool Metabolomics
- timeFrame
- From Baseline to Final Visit (5 weeks)
- description
- Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
Secondary outcomes (1)
- measure
- Relative Composition of Gut Microbiome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion 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%). * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.