Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease

Active, not recruiting

• Conditions: Diverticular Disease of Colon

• Registration Number: NCT06764550
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

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 Timeline

• Study Start: 2020-03-05
• Primary Completion: 2024-07-31
• Status Verified: 2024-11
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the interaction between host factors and gut microbiota	3 years	Assess the interaction between host factors and gut microbiota

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy