Colorectal PolypNCT06603519
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
A study testing Modified Plant-Based Mediterranean Diet in people with Colorectal Polyp and Inflammation, run by University of California, San Diego at 1 site in United States.
Trial summary
This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp, Inflammation, Dietary Intervention
- What is being tested?
- Modified Plant-Based Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated polyps but no current diagnosis of CRC.
Who cannot join
- Inability to provide informed consent and engage in informed consent procedures.
- Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention.
- Pregnant
- Serious illness and in hospice or palliative care for terminal disease
- Swallowing issues, including self-reported difficulty tolerating solids or liquids.
- Active antibiotics use for an ongoing acute infection.
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- Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.
- Participants who plan to relocate to an area not served by UCSD or travel plans that do not permit completion of the study.
- Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of >15
- Uncontrolled disease states:
- Hyper-tension >160/100mmHg
- Exacerbation of underlying gastrointestinal disease, including chronic inflammatory bowel disease or other malabsorptive disorders
- Decompensated cirrhosis
- Previously diagnosed Diabetes Mellitus with HbA1c >9% at screening
- Newly diagnosed diabetes within the past three months, or HbA1c >6.5% at screening in a person not previously diagnosed with diabetes.
- Participants with a history of end-stage renal disease (ESRD) on hemodialysis
- Active infectious diseases (e.g., active tuberculosis < 3 months from symptom onset or positive test, COVID < 1 month from symptom onset or positive test)
- Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases.
- Participants with Type 1 or Type 2 diabetes on insulin
- Participants aged 2: 75 years with Type 2 diabetes taking prescribed medications that can cause hypoglycemia (e.g., sulfonylureas, glinides), or on a prescribed diet
- Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months
- Requiring transfusions/apheresis during study period
- Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years
- Participants with major psychiatric disorders, including major depression, schizophrenia, or psychosis, who have been hospitalized in the past six (6) months or are currently enrolled in treatment programs.
- Hemoglobin <9.5 g/dL at screening
- Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months.
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
University of California, San Diego Altman Clinical and Translational Research Institute
San Diego, California, 92037
About this study
Official title: Determining the Impact of Dietary Intervention on Inflammation and Microbiome Composition in Patients With Recurrent Polyps Post-Colonoscopy.
This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals.
To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.
Read the detailed description
An altered intestinal gut microbiota, i.e. dysbiosis, has been associated with the development of intestinal diseases including inflammatory bowel disease, colorectal cancer (CRC), and metabolic diseases such as obesity, type 2 diabetes mellitus (T2DM), and cardiovascular disease. Metagenomic analyses have revealed microbial biomarkers and ecological signatures in the fecal microbiome of CRC patients, correlating with chronic inflammation and gut dysbiosis. These factors have demonstrated prognostic relevance for CRC akin to other precursors, including conventional adenoma and serrated polyps.
Bowel lavage, a standard practice for facilitating colonoscopies, may affect the interaction between gut microbes and intestinal phenotypes. Standard bowel preparations have immediate impacts on gut microbiota composition, with alterations typically lasting around 14 days before a partial return to baseline. These changes in gut microbial diversity likely contribute to minor colonoscopy complications such as abdominal discomfort, bloating, diarrhea, and constipation during the recovery period.
Post-bowel lavage dietary intervention could potentially minimize lavage-associated side effects by promoting microbial diversity restoration and systemic inflammation reduction. In a previous mouse study, the investigators discovered that the Standard American Diet (SAD) led to the proliferation of opportunistic pathogens following surgical lavage. This change in microbial composition was linked to increased systemic inflammation and a higher incidence of surgical complications. Additionally, they observed that a high-fiber, low-saturated-fat diet-like a whole food, plant-based (WFPB), Med/DASH diet, and modified Mediterranean diet-can reverse this inflammatory phenotype.
However, there is a lack of interventional trials investigating the health benefits of specific dietary interventions following bowel lavage. Therefore, the investigators propose a human intervention study to assess if daily consumption of a high-fiber diet after colonoscopy will alter the intestinal microbiota, decrease inflammation, and improve digestive health.
This will be a controlled intervention study involving 30 subjects who will be enrolled on a rolling basis as they are identified during the recruitment period. The study begins with an initial visit at Week 1, where blood is collected for immune profiling and metabolomics, and participants start weekly stool collection using the S-Wipe method. At Week 2, a GutLab device is installed in participants' homes for daily stool collection. The colonoscopy occurs at Week 4, followed by a 2-week high-fiber diet provided by Thistle. Throughout the study, blood draws (6 mL) are performed at Weeks 1, 4, 6, and 8, while stool samples are collected weekly via S-Wipe and daily via GutLab. Participants log their food intake with a dietitian three times per week during Weeks 3, 5, and 7, and body composition measurements are taken before the colonoscopy and at the final visit. The study aims to quantify how dietary intervention affects post-lavage microbiome, metabolome, and immune response through analysis of blood and stool samples. Optional follow-ups at 1, 3, and 5 years will assess polyp recurrence. This design enables a comprehensive assessment of a high-fiber diet's impact on intestinal microbiota, inflammation, and digestive health in individuals with a history of polyps undergoing colonoscopy.
- Conditions
- Colorectal Polyp, Inflammation, Dietary Intervention, Microbiota, Colorectal Neoplasms, Metabolomics
- Being tested
- Modified Plant-Based Mediterranean Diet
- Keywords
- Dietary Intervention, Inflammation, Microbiome, Polyps, Colonoscopy, Gut Health, Nutrition, Human Microbiome, Fecal Metabolomics, Serum Metabolomics, Metabolomics Analysis
- Medical subject headings
- Inflammation, Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Plant-Based Mediterranean DietDietary supplement
Two-week dietary intervention after the participants' scheduled colonoscopy consisting of vegetarian high-fiber meals. These meals are designed to provide a substantial intake of dietary fiber through a variety of plant-based foods, including whole grains, legumes, fruits, vegetables, nuts, and seeds. Meals will be delivered bi-weekly, and compliance will be monitored through regular check-ins with a study dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention Group | Experimental | Participants in this arm will follow a modified plant-based Mediterranean diet following their colonoscopies. The dietary intervention aims to reduce inflammation and improve gut microbiome composition. Participants' gut bacteria and overall health will be monitored through blood and stool sample collections, focusing on inflammation reduction and metabolic health improvement. Receives: Dietary Supplement: Modified Plant-Based Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Inflammatory Markers and Microbial Metabolites
Measure changes in circulating inflammatory markers (e.g., CRP, IL-6, IL-8, IL-10) and microbial metabolites (e.g., short-chain fatty acids such as butyrate, propionate, and acetate) at four time-points (Weeks 1, 4, 6, and 8) following bowel lavage and adherence to a modified plant-based Mediterranean diet. Gastrointestinal discomfort will be tracked using patient-reported outcome tools, with comparisons to baseline and across all time points.
Measured: 4 time-points throughout the study: Weeks 1, 4, 6, and 8
Secondary outcomes (1)
Changes in Gut Microbiome Composition and Opportunistic Pathogen Abundance
Measure changes in the gut microbiome composition, including alpha diversity (e.g., Shannon index, Simpson index) and beta diversity (e.g., Bray-Curtis dissimilarity, UniFrac distances), along with the abundance of opportunistic pathogens (e.g., Enterococcus faecalis). Associations will be drawn between microbial diversity and composition, colonoscopy outcomes, circulating immune/metabolite markers, and reported gastrointestinal discomfort. Daily fecal samples will undergo metagenomic sequencing and bioinformatic analysis to quantify these metrics over 7 weeks.
Measured: 7 Weeks of fecal sampling: Weeks 2-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Seerave Foundation
- Responsible party
- Principal investigator, Jack Gilbert, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603519
- Sponsor's protocol ID
- 809457
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of Dietary Intervention on Inflammation and Microbiome Composition in Patients With Recurrent Polyps Post-Colonoscopy.
- ClinicalTrials.gov ID
- NCT06603519
- Acronym / sponsor ID
- 809457
- Conditions
- Colorectal Polyp, Inflammation, Dietary Intervention, Microbiota, Colorectal Neoplasms, Metabolomics
- Keywords
- Dietary Intervention, Inflammation, Microbiome, Polyps, Colonoscopy, Gut Health, Nutrition, Human Microbiome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Seerave Foundation
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals.
To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.
Detailed description
An altered intestinal gut microbiota, i.e. dysbiosis, has been associated with the development of intestinal diseases including inflammatory bowel disease, colorectal cancer (CRC), and metabolic diseases such as obesity, type 2 diabetes mellitus (T2DM), and cardiovascular disease. Metagenomic analyses have revealed microbial biomarkers and ecological signatures in the fecal microbiome of CRC patients, correlating with chronic inflammation and gut dysbiosis. These factors have demonstrated prognostic relevance for CRC akin to other precursors, including conventional adenoma and serrated polyps.
Bowel lavage, a standard practice for facilitating colonoscopies, may affect the interaction between gut microbes and intestinal phenotypes. Standard bowel preparations have immediate impacts on gut microbiota composition, with alterations typically lasting around 14 days before a partial return to baseline. These changes in gut microbial diversity likely contribute to minor colonoscopy complications such as abdominal discomfort, bloating, diarrhea, and constipation during the recovery period.
Post-bowel lavage dietary intervention could potentially minimize lavage-associated side effects by promoting microbial diversity restoration and systemic inflammation reduction. In a previous mouse study, the investigators discovered that the Standard American Diet (SAD) led to the proliferation of opportunistic pathogens following surgical lavage. This change in microbial composition was linked to increased systemic inflammation and a higher incidence of surgical complications. Additionally, they observed that a high-fiber, low-saturated-fat diet-like a whole food, plant-based (WFPB), Med/DASH diet, and modified Mediterranean diet-can reverse this inflammatory phenotype.
However, there is a lack of interventional trials investigating the health benefits of specific dietary interventions following bowel lavage. Therefore, the investigators propose a human intervention study to assess if daily consumption of a high-fiber diet after colonoscopy will alter the intestinal microbiota, decrease inflammation, and improve digestive health.
This will be a controlled intervention study involving 30 subjects who will be enrolled on a rolling basis as they are identified during the recruitment period. The study begins with an initial visit at Week 1, where blood is collected for immune profiling and metabolomics, and participants start weekly stool collection using the S-Wipe method. At Week 2, a GutLab device is installed in participants' homes for daily stool collection. The colonoscopy occurs at Week 4, followed by a 2-week high-fiber diet provided by Thistle. Throughout the study, blood draws (6 mL) are performed at Weeks 1, 4, 6, and 8, while stool samples are collected weekly via S-Wipe and daily via GutLab. Participants log their food intake with a dietitian three times per week during Weeks 3, 5, and 7, and body composition measurements are taken before the colonoscopy and at the final visit. The study aims to quantify how dietary intervention affects post-lavage microbiome, metabolome, and immune response through analysis of blood and stool samples. Optional follow-ups at 1, 3, and 5 years will assess polyp recurrence. This design enables a comprehensive assessment of a high-fiber diet's impact on intestinal microbiota, inflammation, and digestive health in individuals with a history of polyps undergoing colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention Group | Experimental | Dietary Supplement: Modified Plant-Based Mediterranean DietParticipants in this arm will follow a modified plant-based Mediterranean diet following their colonoscopies. The dietary intervention aims to reduce inflammation and improve gut microbiome composition. Participants' gut bacteria and overall health will be monitored through blood and stool sample collections, focusing on inflammation reduction and metabolic health improvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated polyps but no current diagnosis of CRC.
Key exclusion criteria (26 listed)
- Inability to provide informed consent and engage in informed consent procedures.
- Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention.
- Pregnant
- Serious illness and in hospice or palliative care for terminal disease
- Swallowing issues, including self-reported difficulty tolerating solids or liquids.
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 |
|---|---|---|
| Modified Plant-Based Mediterranean DietTwo-week dietary intervention after the participants' scheduled colonoscopy consisting of vegetarian high-fiber meals. These meals are designed to provide a substantial intake of dietary fiber through a variety of plant-based foods, including whole grains, legumes, fruits, vegetables, nuts, and seeds. Meals will be delivered bi-weekly, and compliance will be monitored through regular check-ins with a study dietitian. | Dietary supplement | Dietary Intervention Group |
Primary outcome
Changes in Inflammatory Markers and Microbial Metabolites
Time frame: 4 time-points throughout the study: Weeks 1, 4, 6, and 8
Measure changes in circulating inflammatory markers (e.g., CRP, IL-6, IL-8, IL-10) and microbial metabolites (e.g., short-chain fatty acids such as butyrate, propionate, and acetate) at four time-points (Weeks 1, 4, 6, and 8) following bowel lavage and adherence to a modified plant-based Mediterranean diet. Gastrointestinal discomfort will be tracked using patient-reported outcome tools, with comparisons to baseline and across all time points.
1 secondary outcome
Changes in Gut Microbiome Composition and Opportunistic Pathogen Abundance
Time frame: 7 Weeks of fecal sampling: Weeks 2-8
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 5 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Plant-Based Mediterranean Diet in people with Colorectal Polyp and Inflammation, run by University of California, San Diego 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 1 inclusion and 26 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: enrolling by invitation, as of the sponsor's last update on 5 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Inflammatory Markers and Microbial Metabolites (time frame: 4 time-points throughout the study: Weeks 1, 4, 6, and 8). 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 5 May 2026.