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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05795985
Other study ID # 4183
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date March 1, 2023

Study information

Verified date April 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date March 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
calprotectin levels
dosage of calprotectin levels in patients with abdominal pain

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary inflammation assess the degree of intestinal inflammation by fecal calprotectin assay in patients with abdominal pain 3 days
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