Colorectal Cancer PreventionBILMODNCT07162337
BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
A study testing Increased Plant-Based Diet and Decreased Animal-Based Diet in people with Colorectal Cancer Prevention and Colorectal Adenoma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer Prevention, Colorectal Adenoma
- What is being tested?
- Increased Plant-Based Diet and Decreased Animal-Based Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Andrew T. Chan, MD, MPH, 617-726-3212, achan@mgh.harvard.edu
Andrew T. Chan, MD, MPH
About this study
Official title: BILMOD: BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
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.
Read the detailed description
In this research study, the investigators are:
- Investigating the effect of more plant-based and less animal-based food intake on bile acid metabolomic composition in stool among individuals with a history of colorectal adenoma.
- Investigating the effect of more plant-based and less animal-based food intake on plasma bile acid metabolomic composition, the gut microbiome, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer among individuals with a history of colorectal adenoma.
Based on the following evidence:
- Growing evidence indicates that the gut microbiome and its metabolites play important roles in mediating the dietary effects on colorectal cancer risk
- Secondary bile acids are increasingly appreciated as important metabolites underlying the metabolic link between Western diet, the gut microbiome, and colorectal cancer
- Evidence suggests that secondary bile acids trigger a plethora of tumorigenic effects in the colon, including inflammation, oxidative DNA damage, and apoptosis resistance
- Epidemiological studies have revealed that a higher circulating level of secondary bile acids, particularly deoxycholic acid and lithocholic acid, was associated with an increased risk of colorectal cancer
- High fat intake has been repeatedly reported to increase secondary bile acids, but the findings on how other nutrients or foods in Western diet may influence secondary bile acids remain mixed
The research procedures include screening for eligibility, study intervention, and scheduling two clinical research visits:
- Initial visit - immediately before starting the dietary intervention
- 1 week of observation prior to dietary intervention
- 4 weeks of dietary intervention (increasing plant based food and reducing animal-based food)
- Final visit (after completing the dietary intervention)
At the Initial and Final visits, there will be a collection of lifestyle and nutritional questionnaire data, blood samples, and stool samples. The initial visit will establish the baseline data. The 1-week pre-intervention observation will establish baseline food diary data (every 2 days). The 4-week intervention phase will involve phone calls from study staff to guide participants in their diet changes, additional food diary entries (every 2 days), stool sample collection (every 7 days), and body weight reporting (every 7 days).
It is expected that about 40 people will take part in this research study.
This research is being supported by the National Cancer Institute.
- Conditions
- Colorectal Cancer Prevention, Colorectal Adenoma
- Being tested
- Increased Plant-Based Diet and Decreased Animal-Based Diet
- Keywords
- colorectal cancer, colorectal cancer prevention, colorectal adenoma, obesity, western diet
- Medical subject headings
- Colorectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Plant-Based Diet and Decreased Animal-Based DietBehavioural
Self-regulated diet; increased plant-based foods with decreased animal-based foods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Increased Plant-Based Diet and Decreased Animal-Based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Final Visit (5 weeks)
Secondary outcomes (1)
Relative Composition of Gut Microbiome
Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) and metabolites using deep meta'omic profiling in pre- and post- treatment samples.
Measured: From Baseline to Final Visit (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start18 Jun 2026
- Primary completion18 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrew T. Chan, MD, MPH, Massachusetts General Hospital
- Investigators
- Andrew T. Chan, MD, MPH, Principal investigator, Massachusetts General HospitalKai Wang, PhD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162337
- Sponsor's protocol ID
- 25-611
- Acronym
- BILMOD
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Andrew T. Chan, MD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BILMOD: BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
- ClinicalTrials.gov ID
- NCT07162337
- Acronym / sponsor ID
- BILMOD / 25-611
- Conditions
- Colorectal Cancer Prevention, Colorectal Adenoma
- Keywords
- colorectal cancer, colorectal cancer prevention, colorectal adenoma, obesity, western diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this research study, the investigators are:
- Investigating the effect of more plant-based and less animal-based food intake on bile acid metabolomic composition in stool among individuals with a history of colorectal adenoma.
- Investigating the effect of more plant-based and less animal-based food intake on plasma bile acid metabolomic composition, the gut microbiome, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer among individuals with a history of colorectal adenoma.
Based on the following evidence:
- Growing evidence indicates that the gut microbiome and its metabolites play important roles in mediating the dietary effects on colorectal cancer risk
- Secondary bile acids are increasingly appreciated as important metabolites underlying the metabolic link between Western diet, the gut microbiome, and colorectal cancer
- Evidence suggests that secondary bile acids trigger a plethora of tumorigenic effects in the colon, including inflammation, oxidative DNA damage, and apoptosis resistance
- Epidemiological studies have revealed that a higher circulating level of secondary bile acids, particularly deoxycholic acid and lithocholic acid, was associated with an increased risk of colorectal cancer
- High fat intake has been repeatedly reported to increase secondary bile acids, but the findings on how other nutrients or foods in Western diet may influence secondary bile acids remain mixed
The research procedures include screening for eligibility, study intervention, and scheduling two clinical research visits:
- Initial visit - immediately before starting the dietary intervention
- 1 week of observation prior to dietary intervention
- 4 weeks of dietary intervention (increasing plant based food and reducing animal-based food)
- Final visit (after completing the dietary intervention)
At the Initial and Final visits, there will be a collection of lifestyle and nutritional questionnaire data, blood samples, and stool samples. The initial visit will establish the baseline data. The 1-week pre-intervention observation will establish baseline food diary data (every 2 days). The 4-week intervention phase will involve phone calls from study staff to guide participants in their diet changes, additional food diary entries (every 2 days), stool sample collection (every 7 days), and body weight reporting (every 7 days).
It is expected that about 40 people will take part in this research study.
This research is being supported by the National Cancer Institute.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Increased Plant-Based Diet and Decreased Animal-Based Diet | Experimental | Behavioral: Increased Plant-Based Diet and Decreased Animal-Based DietParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased Plant-Based Diet and Decreased Animal-Based DietSelf-regulated diet; increased plant-based foods with decreased animal-based foods | Behavioural | Increased Plant-Based Diet and Decreased Animal-Based Diet |
Primary outcome
Change in Stool Metabolomics
Time frame: From Baseline to Final Visit (5 weeks)
Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
1 secondary outcome
Relative Composition of Gut Microbiome
Time frame: From Baseline to Final Visit (5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Andrew T. Chan, MD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew T. Chan, MD, MPH principal investigator
Massachusetts General Hospital
Kai Wang, PhD study director
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased Plant-Based Diet and Decreased Animal-Based Diet in people with Colorectal Cancer Prevention and Colorectal Adenoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew T. Chan, MD, MPH (617-726-3212, achan@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stool Metabolomics (time frame: From Baseline to Final Visit (5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.