Effects of a Plant-Based Diet on Gut Health After Colonoscopy
Determining the Impact of Dietary Intervention on Inflammation and Microbiome Composition in Patients With Recurrent Polyps Post-Colonoscopy.
This study is testing whether a plant-based Mediterranean diet can improve gut health and reduce inflammation in people after they have a colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06603519 on ClinicalTrials.gov |
What this trial studies
This study investigates how a modified plant-based Mediterranean diet influences gut microbiome composition and inflammation in patients post-colonoscopy. Researchers will analyze stool samples using metagenomic testing to assess gut microorganisms, alongside immune profiling and metabolomic analysis of serum samples. The goal is to understand how dietary changes can enhance gut health and reduce inflammation after bowel preparation for colonoscopy. This multi-faceted approach aims to provide insights into the relationship between diet, gut microbiota, and overall metabolic health.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for their second or third colonoscopy with a history of tubular, villous, or serrated polyps but without a current diagnosis of colorectal cancer.
Not a fit: Patients who are pregnant, have serious illnesses, or have difficulty consuming solid or liquid foods may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve gut health and reduce inflammation in patients undergoing colonoscopy.
How similar studies have performed: Previous studies have shown promising results regarding dietary interventions and gut microbiome health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated polyps but no current diagnosis of CRC. Exclusion Criteria: 1. Inability to provide informed consent and engage in informed consent procedures. 2. Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention. 3. Pregnant 4. Serious illness and in hospice or palliative care for terminal disease 5. Swallowing issues, including self-reported difficulty tolerating solids or liquids. 6. Active antibiotics use for an ongoing acute infection. 7. 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. 8. Participants who plan to relocate to an area not served by UCSD or travel plans that do not permit completion of the study. 9. Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of \>15 Uncontrolled disease states: 10. Hyper-tension \>160/100mmHg 11. Exacerbation of underlying gastrointestinal disease, including chronic inflammatory bowel disease or other malabsorptive disorders 12. Decompensated cirrhosis 13. Previously diagnosed Diabetes Mellitus with HbA1c \>9% at screening 14. Newly diagnosed diabetes within the past three months, or HbA1c \>6.5% at screening in a person not previously diagnosed with diabetes. 15. Participants with a history of end-stage renal disease (ESRD) on hemodialysis 16. Active infectious diseases (e.g., active tuberculosis \< 3 months from symptom onset or positive test, COVID \< 1 month from symptom onset or positive test) 17. Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases. 18. Participants with Type 1 or Type 2 diabetes on insulin 19. 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 20. Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months 21. Requiring transfusions/apheresis during study period 22. Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years 23. 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. 24. Hemoglobin \<9.5 g/dL at screening 25. Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months.
Where this trial is running
San Diego, California
- University of California, San Diego Altman Clinical and Translational Research Institute — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Jack A Gilbert, PhD
- Email: jagilbert@health.ucsd.edu
- Phone: 858-246-5826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.