NCT05795985

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

March 21, 2023

Last Update Submit

April 1, 2023

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

  • inflammation

    assess the degree of intestinal inflammation by fecal calprotectin assay in patients with abdominal pain

    3 days

Study Arms (1)

abdominal pain

patients with abdominal pain

Diagnostic Test: calprotectin levels

Interventions

calprotectin levelsDIAGNOSTIC_TEST

dosage of calprotectin levels in patients with abdominal pain

abdominal pain

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

July 1, 2021

Primary Completion

December 31, 2022

Study Completion

March 1, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Locations

IT(1)