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Microbiota: Its Role in Chronic Inflammation, IDB and Risk of Colorectal Cancer. Evaluation of a Predictive Prognostic Model With Therapeutic Implications

Active, not recruiting
Conditions
IBD (Inflammatory Bowel Disease)
Colon Cancer
Registration Number
NCT07106463
Lead Sponsor
University of Messina
Brief Summary

The gut microbiome is emerging as a crucial factor in several intestinal diseases, contributing to the etiopathogenesis of inflammatory disorders. While most microorganisms reside in the gut and play vital roles in host immunity and nutrition, an imbalance in microbiome composition can trigger chronic intestinal inflammation, increasing the risk of developing colorectal cancer (CRC). Significant quantities of the Gram-negative bacterium Fusobacterium nucleatum have been associated with poorer survival rates and increased resistance to chemotherapy in CRC patients. Furthermore, F. nucleatum has been shown to mediate CRC chemoresistance through activation of the ULK1 autophagy pathway. Recent studies have reported the ability of F. nucleatum to induce inflammation in the gut epithelium and activate a specific component of the immune system, the NLRP3 inflammasome, leading to the release of IL-1ß, a pro-inflammatory cytokine. The aim of this project is to investigate the role of F. nucleatum in the development of chronic inflammatory bowel disease (IBD) and CRC by exploring a potential connection between its involvement in NLRP3 inflammasome activation and its ability to promote chemoresistance through autophagy modulation. The working hypothesis posits that these two biological processes are strongly interconnected and may significantly influence the interaction between the gut microbiota and host immunity, ultimately affecting disease progression in IBD and CRC. The proposed research plan includes:

i) in vitro characterization of the impact of F. nucleatum infection on NLRP3 inflammasome activation, autophagy induction, and CRC development and progression; ii) determination of the correlation between F. nucleatum abundance and chronic IBD, as well as early and advanced stages of colorectal carcinomas; iii) implementation of radiomic analyses to accurately distinguish cancerous from non-cancerous colon tissue and to identify radiomic signatures indicative of specific tumor-host interactions, including inflammation and/or autophagy. This research aims to generate novel insights into the interplay between the microbiota and chronic degenerative diseases, thereby contributing to the development of innovative microbiota-based therapeutic strategies. This proposal may represent an effective approach to predict patient outcomes and improve the prognosis of individuals with IBD and CRC by enabling differential patient management, correlating F. nucleatum levels with inflammation and autophagy, and potentially informing combinatorial treatments to overcome chemoresistance.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria

Individuals in generally good health

Individuals diagnosed with Inflammatory Bowel Disease (IBD)

Individuals diagnosed with early-stage Colorectal Cancer (CRC)

Individuals with locally advanced Colorectal Cancer (CRC)

Individuals with metastatic Colorectal Cancer (CRC)

Exclusion Criteria

Individuals diagnosed with other malignancies

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Levels of NLRP3 inflammasome activation, autophagy markers, and colorectal cancer-related molecular changes in in vitro models infected with F. nucleatum.through study completion, an average of 1 year
Secondary Outcome Measures
NameTimeMethod
Quantification of F. nucleatum levels in biological samples from individuals with chronic inflammatory bowel disease and colorectal carcinomas.Baseline

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria "G.Martino"

🇮🇹

Messina, Italy

Azienda Ospedaliera Universitaria "G.Martino"
🇮🇹Messina, Italy

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