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NCT Number: NCT06764550

Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years.
  • Belonging to one of the following groups:
  • Patients with diverticula of the colon without symptoms.
  • Patients symptomatic for diverticular disease.
  • 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).

Treatment and study plan

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

Other

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

Primary outcomes

  1. Assess the interaction between host factors and gut microbiota

    Time frame: 3 years

    Assess the interaction between host factors and gut microbiota

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: GR-Barbaro

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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