ClinicalTrials.gg
Active, not recruitingNCT06764550GR-BarbaroUpdated Jan 8, 2025

Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease

An observational study in Diverticular Disease of Colon, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Diverticular Disease of Colon
03

In context

Diverticulosis, Colonic

23 studies on the registry are indexed under Diverticulosis, Colonic; 4 are open to participants now.

This study's enrollment of 150 is below the median of 225 across 10 observational studies indexed under Diverticulosis, Colonic.

Browse Diverticulosis, Colonic studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects were recruited from the endoscopy room.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherThis 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.

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What researchers measure

Primary outcomes

  1. Assess the interaction between host factors and gut microbiota

    Assess the interaction between host factors and gut microbiota

    Time frame: 3 years

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2020 to primary completion in Jul 2024, 52 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2025
First posted
Jan 8, 2025
StartActual
Mar 5, 2020
Primary completionActual
Jul 31, 2024
CompletionEst.
Mar 31, 2025
Last update
Jan 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06764550
Responsible party
Sponsor
First posted
Jan 8, 2025
Start date
Mar 5, 2020
Primary completion
Jul 31, 2024
Completion
Mar 31, 2025 (estimated)
Last update
Jan 8, 2025

Study contacts

Maria Raffaella Barbaro, Biologist
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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