Intestinal InflammationPRIMENCT06149949
the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage
An observational study of Intestinal Inflammation and Rhinosinusitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease. The main questions it aims to answer are: Evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease Evaluate any relationships… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intestinal Inflammation, Rhinosinusitis
- What is being tested?
- Observational study
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled. All patients will be given questionnaires at baseline on quality of life and symptoms of intestinal bowel disease and the presence of symptoms correlated with rhinosinusitis cronic. Patients who respond affirmatively to the presence of rhinosinus symptoms will have their blood drawn according to clinical practice and deliver a stool sample for gut microbiota analysis. In addition, all will undergo psychological evaluation. Patients with rhinosinusitis cronic will undergo specialist otolaryngologist evaluation according to clinical practice.
Who may be able to join
- Age between 18 years and 70 years.
- Diagnosis of Crohn's disease or Ulcerative Rectocolitis
- Willingness to participate in the study and ability to comply with and understand the study protocol.
- Patients with a previous diagnosis of Crohn's disease or Ulcerative Rectocolitis for at least 3 months prior to screening
- Signature of informed consent
Who cannot join
- Age <18 years
- Refusal of informed consent
About this study
Official title: Ambispective Pilot Study on the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage
The goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease.
The main questions it aims to answer are:
Read more
- Evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease
- Evaluate any relationships between chronic rhinosinusitis and the clinical course of intestinal bowel disease -Evaluate the influence of chronic rhinosinusitis on the response to biologic therapies for intestinal bowel disease
- Evaluate mucosal barrier damage in patients with chronic rhinosinusitis and intestinal bowel disease by collecting blood and stool samples according to clinical practice
- Presence of enterotoxin sensitization to S. Aureus in patients with intestinal bowel disease
- Histopathological evaluation: reevaluation of biopsy slides performed according to clinical practice will be performed in patients with chronic rhinosinusitis and intestinal bowel disease in order to quantify the proportion of eosinophilic infiltrate at the intestinal level and to assess any differences from the population with intestinal bowel disease only.
Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled.
- Conditions
- Intestinal Inflammation, Rhinosinusitis
- Being tested
- Observational study
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
the aim of the study is to define the prevalence of rhinosinusitis cronic in intestinal bowel disease patients, to assess how it affects the patient's quality of life, and any correlations between these two entities
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal InflammationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149949
- Sponsor's protocol ID
- 6126
- Acronym
- PRIME
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Pilot Study on the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage
- ClinicalTrials.gov ID
- NCT06149949
- Acronym / sponsor ID
- PRIME / 6126
- Conditions
- Intestinal Inflammation, Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Nov 2023 (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 goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease.
The main questions it aims to answer are:
- Evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease
- Evaluate any relationships between chronic rhinosinusitis and the clinical course of intestinal bowel disease -Evaluate the influence of chronic rhinosinusitis on the response to biologic therapies for intestinal bowel disease
- Evaluate mucosal barrier damage in patients with chronic rhinosinusitis and intestinal bowel disease by collecting blood and stool samples according to clinical practice
- Presence of enterotoxin sensitization to S. Aureus in patients with intestinal bowel disease
- Histopathological evaluation: reevaluation of biopsy slides performed according to clinical practice will be performed in patients with chronic rhinosinusitis and intestinal bowel disease in order to quantify the proportion of eosinophilic infiltrate at the intestinal level and to assess any differences from the population with intestinal bowel disease only.
Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled. All patients will be given questionnaires at baseline on quality of life and symptoms of intestinal bowel disease and the presence of symptoms correlated with rhinosinusitis cronic. Patients who respond affirmatively to the presence of rhinosinus symptoms will have their blood drawn according to clinical practice and deliver a stool sample for gut microbiota analysis. In addition, all will undergo psychological evaluation. Patients with rhinosinusitis cronic will undergo specialist otolaryngologist evaluation according to clinical practice.
Key inclusion criteria (5 listed)
- Age between 18 years and 70 years.
- Diagnosis of Crohn's disease or Ulcerative Rectocolitis
- Willingness to participate in the study and ability to comply with and understand the study protocol.
- Patients with a previous diagnosis of Crohn's disease or Ulcerative Rectocolitis for at least 3 months prior to screening
- Signature of informed consent
Key exclusion criteria (2 listed)
- Age <18 years
- Refusal of informed consent
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 |
|---|---|---|
| Observational studythe aim of the study is to define the prevalence of rhinosinusitis cronic in intestinal bowel disease patients, to assess how it affects the patient's quality of life, and any correlations between these two entities | Other | – |
Primary outcome
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
Time frame: 1 hour
To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Inflammation and Rhinosinusitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease (time frame: 1 hour). 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 29 Nov 2023.