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CompletedNCT05795985Updated Apr 4, 2023

Role of Faecal Calprotectin in Patients With Abdominal Pain

An observational study in Inflammation, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
146
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammation

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03

In context

Inflammation

3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.

This study's enrollment of 146 is above the median of 95 across 913 observational studies indexed under Inflammation.

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Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Browse Fondazione Policlinico Universitario Agostino Gemelli IRCCS studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
146 participants (actual)
Patient registry
No

Groups and cohorts

  • abdominal pain

    patients with abdominal pain

    Diagnostic Test: calprotectin levels

Interventions

  • Diagnostic testcalprotectin levels

    dosage of calprotectin levels in patients with abdominal pain

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What researchers measure

Primary outcomes

  1. inflammation

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

    Time frame: 3 days

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, 00168, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Dec 2022, 17 months.

Of 383 non-industry observational studies under Inflammation, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 83. This study's 17 months is below that.

Counting every sponsor, half of 402 studies reached it within 36 months; a quarter within 18 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2023
First posted
Apr 3, 2023
StartActual
Jul 1, 2021
Primary completionActual
Dec 31, 2022
CompletionActual
Mar 1, 2023
Last update
Apr 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05795985
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
OJETTI VERONICA (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Apr 3, 2023
Start date
Jul 1, 2021
Primary completion
Dec 31, 2022
Completion
Mar 1, 2023
Last update
Apr 4, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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