Clinical trial · Interventional
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
Determining the Impact of Dietary Intervention on Inflammation and Microbiome Composition in Patients With Recurrent Polyps Post-Colonoscopy.
NCT06603519CI-TRIAL-00110460enrolling by invitationN/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 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.
Conditions
Conditions (6)
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Polyp | — | UNRESOLVED | — |
| Dietary Intervention | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Metabolomics | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified Plant-Based Mediterranean Diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary Intervention Group
- description
- 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.
- interventionNames
- Dietary Supplement: Modified Plant-Based Mediterranean Diet
Primary outcomes (1)
- measure
- Changes in Inflammatory Markers and Microbial Metabolites
- timeFrame
- 4 time-points throughout the study: Weeks 1, 4, 6, and 8
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.