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IBD (Inflammatory Bowel Disease)NCT07106463

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

An observational study of IBD (Inflammatory Bowel Disease) and Colon Cancer, run by University of Messina at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
100 participants
Where
1 siteItaly
Study dates
30 Aug 2024to 29 Aug 2026
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: individuals in health, with IBD, with early CRC, with local advanced CRC and metastatic CRC (20 subjects for arms).

Who may be able to join

  • 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)

Who cannot join

  • Individuals diagnosed with other malignancies

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Azienda Ospedaliera Universitaria "G.Martino"

    Messina, Italy, 98124

Other trials in Italy

About this study

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:

  1. 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.
Medical subject headings
Inflammatory Bowel Diseases, Colonic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Levels of NLRP3 inflammasome activation, autophagy markers, and colorectal cancer-related molecular changes in in vitro models infected with F. nucleatum.

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  1. Quantification of F. nucleatum levels in biological samples from individuals with chronic inflammatory bowel disease and colorectal carcinomas.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start30 Aug 2024
  3. Primary completion29 Aug 2026 (estimated)
  4. Study completion29 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07106463
Sponsor's protocol ID
07-24
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
6 Aug 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of IBD (Inflammatory Bowel Disease) and Colon Cancer, run by University of Messina at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of NLRP3 inflammasome activation, autophagy markers, and colorectal cancer-related molecular changes in in vitro models infected with F. nucleatum. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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