Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy

Enrolling by invitation · Not applicable

Conditions studied: Colorectal Polyp, Inflammation, Dietary Intervention, Microbiota, Colorectal Neoplasms, Metabolomics

In brief

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.

Key facts

Study ID

NCT06603519

Run by

University of California, San Diego

People needed

30

Starts

2025-03-04

Expected to finish

2026-12-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated polyps but no current diagnosis of CRC.

You may not qualify if…

• 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.
• 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

Where it is running

• University of California, San Diego Altman Clinical and Translational Research Institute — San Diego, California, United States

Full record on ClinicalTrials.gov

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