NCT06764550

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

January 8, 2025

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

January 2, 2025

Last Update Submit

January 2, 2025

Conditions

Diverticular Disease of Colon

Outcome Measures

Primary Outcomes (1)

  • Assess the interaction between host factors and gut microbiota

    Assess the interaction between host factors and gut microbiota

    3 years

Study Arms (3)

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.

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.

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.

Interventions

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.

Healthy subjectsPatients with diverticulosisPatients with symptomatic uncomplicated diverticular disease

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects were recruited from the endoscopy room.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Colonic biopsies

MeSH Terms

Conditions

Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Maria Raffaella Barbaro, Biologist

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

March 5, 2020

Primary Completion

July 31, 2024

Study Completion

March 31, 2025

Last Updated

January 8, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)