Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease (GR-Barbaro)

January 2, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease - Caratterizzazione Dei Meccanismi Molecolari e Del Microbiota Nella Malattia Diverticolare Del Colon

The pathogenesis of diverticular disease is likely multifactorial in origin. This project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The pathogenesis of diverticular disease is likely multifactorial in origin. Some studies have demonstrated the role of genetic factors, while others have highlighted the role of environmental factors. The present project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects were recruited from the endoscopy room.

Description

Inclusion Criteria:

  • Age between 18 and 75 years.

  • Belonging to one of the following groups:

    1. Patients with diverticula of the colon without symptoms.
    2. Patients symptomatic for diverticular disease.
    3. Subjects undergoing colonoscopy for colorectal cancer prevention or follow-up of previous polypectomies, asymptomatic for digestive symptoms.
  • Obtaining informed consent.

Exclusion Criteria:

  • Acute complicated diverticulitis (bleeding, perforation)
  • Previous colon surgery
  • Antibiotics or laxatives within the past 90 days
  • Pregnancy and/or lactation
  • Systemic and psychiatric disorders
  • Asthma, food allergies and other allergic-type disorders
  • Possible diseases leading to intestinal bacterial contamination (diabetes, blind loop syndrome, rheumatologic diseases).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
Subjects who are asymptomatic for digestive symptoms and without diverticula.
Other: This is an observational study, participants are not assigned an intervention as part of the study.
This is an observational study, participants are not assigned an intervention as part of the study.
Patients with diverticulosis
Patients with diverticula and without symptoms.
Other: This is an observational study, participants are not assigned an intervention as part of the study.
This is an observational study, participants are not assigned an intervention as part of the study.
Patients with symptomatic uncomplicated diverticular disease
Patients with diverticula and with symptoms.
Other: This is an observational study, participants are not assigned an intervention as part of the study.
This is an observational study, participants are not assigned an intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the interaction between host factors and gut microbiota
Time Frame: 3 years
Assess the interaction between host factors and gut microbiota
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Maria Raffaella Barbaro, Biologist, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Actual)

July 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-Barbaro
  • GR-2018-12367062 (Other Grant/Funding Number: Ministero della Salute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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