IBS (Irritable Bowel Syndrome)SARANCT07922668
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
An observational study of IBS (Irritable Bowel Syndrome) and Rosacea, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
To describe the prevalence of rosacea in a population of patients with IBS followed at a tertiary-level university medical center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS (Irritable Bowel Syndrome), Rosacea
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 1 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of all adult patients evaluated in the past 12 months at the outpatient clinics of the Clinical Operational Unit (UOC) of Internal Medicine and Digestive Physiopathology and the Clinical Operational Unit (UOC) of Dermatology at the IRCCS University Hospital of Bologna, Sant'Orsola Polyclinic, with a documented diagnosis of IBS and/or rosacea. Patients for whom both conditions are already documented in their outpatient medical records will be included.
Who may be able to join
- Age ≥18 years
- Evaluation at the Internal Medicine, Digestive Physiopathology, and Dermatology outpatient clinics of the IRCCS AOU Policlinico di Sant'Orsola in Bologna within the last 12 months.
- Presence of a confirmed diagnosis of IBS and/or rosacea documented in the outpatient medical record.
- Availability of clinical data essential for the analysis.
Who cannot join
- Age <18 years.
- Unable to confirm the presence of IBS and/or rosacea.
- Insufficient clinical data for analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Giovanni Barbara, MD, 051 2144103, giovanni.barbara@unibo.it
About this study
Official title: Sintomi Addominali e RosaceA: Studio Osservazionale Sull'Associazione Tra Sindrome Dell'Intestino Irritabile (IBS) e l'Asse Intestino-pelle
To describe the prevalence of rosacea in a population of patients with IBS followed at a tertiary-level university medical center.
Read the detailed description
The growing evidence of a correlation between gastrointestinal disorders-particularly irritable bowel syndrome (IBS)-and rosacea suggests the existence of shared pathophysiological mechanisms linked to the gut-skin axis. However, the available data derive primarily from international epidemiological studies, while information obtained from real-world clinical practice in Italy is limited. Therefore, it is of interest to evaluate the prevalence and clinical characteristics of the association between rosacea and IBS in an outpatient population attending a tertiary-level university center, in order to provide observational data useful for better characterizing this patient population.
- Conditions
- IBS (Irritable Bowel Syndrome), Rosacea
- Keywords
- IBS, gut-skin axis
- Medical subject headings
- Irritable Bowel Syndrome, Rosacea
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients diagnosed with rosacea among the patients diagnosed with IBS included in the study.
Measured: 4 months
Secondary outcomes (1)
Distribution of clinical subtypes of rosacea in patients with and without IBS. Age and sex distribution in the two groups. Prevalence of major gastrointestinal comorbidities.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Sep 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Barbara, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922668
- Sponsor's protocol ID
- SARA
- Acronym
- SARA
- Status last verified
- Sep 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintomi Addominali e RosaceA: Studio Osservazionale Sull'Associazione Tra Sindrome Dell'Intestino Irritabile (IBS) e l'Asse Intestino-pelle
- ClinicalTrials.gov ID
- NCT07922668
- Acronym / sponsor ID
- SARA / SARA
- Conditions
- IBS (Irritable Bowel Syndrome), Rosacea
- Keywords
- IBS, gut-skin axis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Nov 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.
To describe the prevalence of rosacea in a population of patients with IBS followed at a tertiary-level university medical center.
Detailed description
The growing evidence of a correlation between gastrointestinal disorders-particularly irritable bowel syndrome (IBS)-and rosacea suggests the existence of shared pathophysiological mechanisms linked to the gut-skin axis. However, the available data derive primarily from international epidemiological studies, while information obtained from real-world clinical practice in Italy is limited. Therefore, it is of interest to evaluate the prevalence and clinical characteristics of the association between rosacea and IBS in an outpatient population attending a tertiary-level university center, in order to provide observational data useful for better characterizing this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of all adult patients evaluated in the past 12 months at the outpatient clinics of the Clinical Operational Unit (UOC) of Internal Medicine and Digestive Physiopathology and the Clinical Operational Unit (UOC) of Dermatology at the IRCCS University Hospital of Bologna, Sant'Orsola Polyclinic, with a documented diagnosis of IBS and/or rosacea. Patients for whom both conditions are already documented in their outpatient medical records will be included.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Evaluation at the Internal Medicine, Digestive Physiopathology, and Dermatology outpatient clinics of the IRCCS AOU Policlinico di Sant'Orsola in Bologna within the last 12 months.
- Presence of a confirmed diagnosis of IBS and/or rosacea documented in the outpatient medical record.
- Availability of clinical data essential for the analysis.
Key exclusion criteria (3 listed)
- Age <18 years.
- Unable to confirm the presence of IBS and/or rosacea.
- Insufficient clinical data for analysis.
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
Percentage of patients diagnosed with rosacea among the patients diagnosed with IBS included in the study.
Time frame: 4 months
1 secondary outcome
Distribution of clinical subtypes of rosacea in patients with and without IBS. Age and sex distribution in the two groups. Prevalence of major gastrointestinal comorbidities.
Time frame: 4 months
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 6 Nov 2026.
- 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.
Giovanni Barbara, MD 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 IBS (Irritable Bowel Syndrome) and Rosacea, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 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?
Contact Giovanni Barbara, MD (0512144103, giovanni.barbara@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients diagnosed with rosacea among the patients diagnosed with IBS included in the study. (time frame: 4 months). 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 6 Nov 2026.