Role of Faecal Calprotectin in Patients With Abdominal Pain

April 1, 2023 updated by: OJETTI VERONICA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with abdominal pain and/or diarrhea and/or rectal bleeding accessing the emergency department

Description

Inclusion Criteria:

  • patients with abdominal pain and/or diarrhea and/or rectal bleeding

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
abdominal pain
patients with abdominal pain
Diagnostic test: calprotectin levels
dosage of calprotectin levels in patients with abdominal pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation
Time Frame: 3 days
assess the degree of intestinal inflammation by fecal calprotectin assay in patients with abdominal pain
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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