Diverticular Disease of ColonGR-BarbaroNCT06764550
Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease
An observational study of Diverticular Disease of Colon, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diverticular Disease of Colon
- What is being tested?
- This is an observational study, participants are not assigned an intervention as part of the study.
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2020to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were recruited from the endoscopy room.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease - Caratterizzazione Dei Meccanismi Molecolari e Del Microbiota Nella Malattia Diverticolare Del Colon
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.
- Conditions
- Diverticular Disease of Colon
- Being tested
- This is an observational study, participants are not assigned an intervention as part of the study.
- Medical subject headings
- Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Subjects who are asymptomatic for digestive symptoms and without diverticula. Receives: 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. Receives: 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. Receives: Other: This is an observational study, participants are not assigned an intervention as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the interaction between host factors and gut microbiota
Assess the interaction between host factors and gut microbiota
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start5 Mar 2020
- Primary completion31 Jul 2024
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular Disease of ColonStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Raffaella Barbaro, Biologist, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764550
- Sponsor's protocol ID
- GR-Barbaro
- Other IDs
- GR-2018-12367062
- Acronym
- GR-Barbaro
- Status last verified
- Nov 2024
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease - Caratterizzazione Dei Meccanismi Molecolari e Del Microbiota Nella Malattia Diverticolare Del Colon
- ClinicalTrials.gov ID
- NCT06764550
- Acronym / sponsor ID
- GR-Barbaro / GR-Barbaro
- Conditions
- Diverticular Disease of Colon
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: This is an observational study, participants are not assigned an intervention as part of the study.Subjects who are asymptomatic for digestive symptoms and without diverticula. |
| Patients with diverticulosis | – | Other: This is an observational study, participants are not assigned an intervention as part of the study.Patients with diverticula and without symptoms. |
| Patients with symptomatic uncomplicated diverticular disease | – | Other: This is an observational study, participants are not assigned an intervention as part of the study.Patients with diverticula and with symptoms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited from the endoscopy room.
Key inclusion criteria (6 listed)
- Age between 18 and 75 years.
- Belonging to one of the following groups:
- Obtaining informed consent.
Key exclusion criteria (7 listed)
- Acute complicated diverticulitis (bleeding, perforation)
- Previous colon surgery
- Antibiotics or laxatives within the past 90 days
- Pregnancy and/or lactation
- Systemic and psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy subjects, Patients with diverticulosis, Patients with symptomatic uncomplicated diverticular disease |
Primary outcome
Assess the interaction between host factors and gut microbiota
Time frame: 3 years
Assess the interaction between host factors and gut microbiota
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Raffaella Barbaro, Biologist principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease of Colon, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the interaction between host factors and gut microbiota (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.