Diverticular Disease of ColonNCT07681505
Analysis of the Role of the Microbiota in Diverticular Disease
An observational study of Diverticular Disease of Colon and Acute Diverticulitis, run by Hospital of Navarra at 1 site in Spain.
Trial summary
A single-center, prospective observational cohort study conducted at the University Hospital of Navarra. The primary objective is to expand knowledge of diverticular disease and its pathological variants, as well as the influence of the microbiota in our environment, both clinically and molecularly; to describe the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of Colon, Acute Diverticulitis, Gut Microbiota
- How many people
- 285 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2027to 1 Jan 2032
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients attended in outpatient clinics, the gastrointestinal endoscopy unit, and the emergency department at the University Hospital of Navarra
Who may be able to join
- Age 18 or older.
- Signing of the informed consent form.
- Assignment to one of the study groups mentioned above.
Who cannot join
- An episode of acute diverticulitis located in the right colon or transverse colon.
- Antibiotic treatment within the six weeks prior to the episode (except for antibiotics started in the emergency department or within 24 hours prior to sample collection).
- Mechanical bowel preparation within the three weeks prior to sample collection.
- Diagnosis of colorectal cancer.
- Diagnosis of inflammatory bowel disease.
- Failure to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
A single-center, prospective observational cohort study conducted at the University Hospital of Navarra. The primary objective is to expand knowledge of diverticular disease and its pathological variants, as well as the influence of the microbiota in our environment, both clinically and molecularly; to describe the clinical and pathological characteristics of patients with diverticulosis and acute diverticulitis; to analyze any differences in the microbiota; and to identify the risk factors and groups associated with diverticular disease in order to establish the best strategies for prevention and treatment.
- Medical subject headings
- Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy patient | Patients identified in outpatient clinics for general and gastrointestinal surgery who have previously undergone a colonoscopy with no evidence of diverticulosis. | |
| Patients with asymptomatic diverticulosis | Patients referred by the Endoscopy Unit of the Gastroenterology Department following the detection of diverticula during colonoscopy, with no clinical signs suggestive of diverticular disease. | |
| Patients with a first episode of acute diverticulitis | Patients who present to the Emergency Department and are diagnosed with a first episode of acute diverticulitis of the left colon, confirmed by abdominal and pelvic CT scan, and who are evaluated and treated by the Department of General and Gastrointestinal Surgery. | |
| Patients with recurrent acute diverticulitis | Patients previously included in the study following a first episode of acute diverticulitis who present with a documented recurrence during follow-up (2 years), and who are re-evaluated and treated in the Emergency Department by the Department of General and Digestive Surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the microbiota influences the development of diverticulosis
To investigate whether the microbiota influences the development of diverticulosis and a first episode of acute diverticulitis.
Measured: From the diagnosis until two years
Secondary outcomes (3)
To investigate how the microbiota affects the therapeutic response in patients presenting with a first episode of acute diverticulitis.
To investigate how the microbiota affects the therapeutic response in patients presenting with a first episode of acute diverticulitis.
Measured: From the diagnosis until 8 weeks
To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.
To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.
Measured: From the diagnosis until 8 weeks
To analyze the microbiota of patients who experience a recurrence of acute diverticulitis following a first episode compared to those who do not experience a recurrence within the first two years after the episode of acute diverticulitis.
To analyze the microbiota of patients who experience a recurrence of acute diverticulitis following a first episode compared to those who do not experience a recurrence within the first two years after the episode of acute diverticulitis.
Measured: From the diagnosis until 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2032 (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.
- 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
- 285 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Eguaras, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681505
- Sponsor's protocol ID
- PI_2025/84
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Role of the Microbiota in Diverticular Disease
- ClinicalTrials.gov ID
- NCT07681505
- Acronym / sponsor ID
- PI_2025/84
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 2 Jul 2026 (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.
A single-center, prospective observational cohort study conducted at the University Hospital of Navarra. The primary objective is to expand knowledge of diverticular disease and its pathological variants, as well as the influence of the microbiota in our environment, both clinically and molecularly; to describe the clinical and pathological characteristics of patients with diverticulosis and acute diverticulitis; to analyze any differences in the microbiota; and to identify the risk factors and groups associated with diverticular disease in order to establish the best strategies for prevention and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy patient | – | –Patients identified in outpatient clinics for general and gastrointestinal surgery who have previously undergone a colonoscopy with no evidence of diverticulosis. |
| Patients with asymptomatic diverticulosis | – | –Patients referred by the Endoscopy Unit of the Gastroenterology Department following the detection of diverticula during colonoscopy, with no clinical signs suggestive of diverticular disease. |
| Patients with a first episode of acute diverticulitis | – | –Patients who present to the Emergency Department and are diagnosed with a first episode of acute diverticulitis of the left colon, confirmed by abdominal and pelvic CT scan, and who are evaluated and treated by the Department of General and Gastrointestinal Surgery. |
| Patients with recurrent acute diverticulitis | – | –Patients previously included in the study following a first episode of acute diverticulitis who present with a documented recurrence during follow-up (2 years), and who are re-evaluated and treated in the Emergency Department by the Department of General and Digestive Surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients attended in outpatient clinics, the gastrointestinal endoscopy unit, and the emergency department at the University Hospital of Navarra
Key inclusion criteria (3 listed)
- Age 18 or older.
- Signing of the informed consent form.
- Assignment to one of the study groups mentioned above.
Key exclusion criteria (6 listed)
- An episode of acute diverticulitis located in the right colon or transverse colon.
- Antibiotic treatment within the six weeks prior to the episode (except for antibiotics started in the emergency department or within 24 hours prior to sample collection).
- Mechanical bowel preparation within the three weeks prior to sample collection.
- Diagnosis of colorectal cancer.
- Diagnosis of inflammatory bowel disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the microbiota influences the development of diverticulosis
Time frame: From the diagnosis until two years
To investigate whether the microbiota influences the development of diverticulosis and a first episode of acute diverticulitis.
3 secondary outcomes
To investigate how the microbiota affects the therapeutic response in patients presenting with a first episode of acute diverticulitis.
Time frame: From the diagnosis until 8 weeks
To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.
Time frame: From the diagnosis until 8 weeks
To analyze the microbiota of patients who experience a recurrence of acute diverticulitis following a first episode compared to those who do not experience a recurrence within the first two years after the episode of acute diverticulitis.
Time frame: From the diagnosis until 2 years
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 2 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Acute Diverticulitis, run by Hospital of Navarra at 1 site in Spain.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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 Spain. 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?
To investigate the microbiota influences the development of diverticulosis (time frame: From the diagnosis until two 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 2 Sep 2026.