Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease

NCT ID: NCT06764550

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-05

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Diverticular Disease of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy subjects

Subjects who are asymptomatic for digestive symptoms and without diverticula.

This is an observational study, participants are not assigned an intervention as part of the study.

Intervention Type OTHER

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.

This is an observational study, participants are not assigned an intervention as part of the study.

Intervention Type OTHER

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.

This is an observational study, participants are not assigned an intervention as part of the study.

Intervention Type OTHER

This is an observational study, participants are not assigned an intervention as part of the study.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Raffaella Barbaro, Biologist

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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GR-2018-12367062

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GR-Barbaro

Identifier Type: -

Identifier Source: org_study_id

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