InflammationNCT05795985
Role of Faecal Calprotectin in Patients With Abdominal Pain
An observational study of Inflammation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- calprotectin levels
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 1 Mar 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: patients with abdominal pain and/or diarrhea and/or rectal bleeding accessing the emergency department
Who may be able to join
- patients with abdominal pain and/or diarrhea and/or rectal bleeding
Who cannot join
- patients with age < 18 years
- pregnant women;
- patients with oncological, cardiological, nephrological terminal diseases;
- patients on antibiotic therapy or who have taken it during the last month;
- patients with a history of colic resection or gastrointestinal surgery;
- patients with a previous diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Faecal Calprotectin in Patients Presenting to the Emergency Department With Abdominal Pain
The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between "organic" or "functional" form and its determination could be helpful to select patients for further examinations, in the context of emergency setting.
- Conditions
- Inflammation
- Being tested
- calprotectin levels
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calprotectin levelsDiagnostic test
dosage of calprotectin levels in patients with abdominal pain
| Study group | Role | What they receive |
|---|---|---|
| abdominal pain | patients with abdominal pain Receives: Diagnostic Test: calprotectin levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation
assess the degree of intestinal inflammation by fecal calprotectin assay in patients with abdominal pain
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jul 2021
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OJETTI VERONICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795985
- Sponsor's protocol ID
- 4183
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Faecal Calprotectin in Patients Presenting to the Emergency Department With Abdominal Pain
- ClinicalTrials.gov ID
- NCT05795985
- Acronym / sponsor ID
- 4183
- Conditions
- Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Apr 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 evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between "organic" or "functional" form and its determination could be helpful to select patients for further examinations, in the context of emergency setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abdominal pain | – | Diagnostic Test: calprotectin levelspatients with abdominal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with abdominal pain and/or diarrhea and/or rectal bleeding accessing the emergency department
Key inclusion criteria (1 listed)
- patients with abdominal pain and/or diarrhea and/or rectal bleeding
Key exclusion criteria (6 listed)
- patients with age < 18 years
- pregnant women;
- patients with oncological, cardiological, nephrological terminal diseases;
- patients on antibiotic therapy or who have taken it during the last month;
- patients with a history of colic resection or gastrointestinal surgery;
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 |
|---|---|---|
| calprotectin levelsdosage of calprotectin levels in patients with abdominal pain | Diagnostic test | abdominal pain |
Primary outcome
inflammation
Time frame: 3 days
assess the degree of intestinal inflammation by fecal calprotectin assay in patients with abdominal pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
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 Inflammation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 1 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
inflammation (time frame: 3 days). 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 4 Apr 2023.