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

NCT06603519 | Enrolling By Invitation

• 1 other identifier: 809457
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Colorectal Polyp; Inflammation; Dietary Intervention; Microbiota; Colorectal Neoplasms; Metabolomics

Keywords

Dietary Intervention; Inflammation; Microbiome; Polyps; Colonoscopy; Gut Health; Nutrition; Human Microbiome; Fecal Metabolomics; Serum Metabolomics; Metabolomics Analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  4 time-points throughout the study: Weeks 1, 4, 6, and 8

Secondary Outcomes (1)

• Changes in Gut Microbiome Composition and Opportunistic Pathogen Abundance

  7 Weeks of fecal sampling: Weeks 2-8

Study Arms (1)

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.

Dietary Supplement: Modified Plant-Based Mediterranean Diet

Interventions

Modified Plant-Based Mediterranean Diet DIETARY_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.

Dietary Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Seerave Foundation: collaborator

Study Sites (1)

University of California, San Diego Altman Clinical and Translational Research Institute

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Inflammation; Colorectal Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)