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Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.

Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis and Its Predictive Role for Inflammatory Bowel Disease Occurrence: a Prospective, Long-term, Controlled Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04190108
Enrollment
259
Registered
2019-12-09
Start date
2016-01-02
Completion date
2019-10-31
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Psoriatic Arthritis

Brief summary

Background.Recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal inflammation. Primary objective of present study was to evaluate the presence of occult bowel inflammation in patients with PsA as expressed by elevated levels of FC. Secondary objectives were to investigate the correlation between the levels FC and clinical and laboratory features, and the outcome of CF-positive patients in terms of IBD development.

Detailed description

A number of studies evaluated the presence of occult intestinal inflammation by using FC assay in patients with axial SpA. In 2000, a study conducted in PsA patients without bowel symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid aggregates.Present prospective case-control study was designed to investigate occult intestinal inflammation by using FC assay in consecutive patients with PsA at onset, and who had no abdominal symptoms. Five Italian Centers contributed to patients recruitment adopting the same inclusion and exclusion criteria over a 3 year period. FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. This automated method is a particle enhanced turbidimetric immunoassay employing polyclonal antibodies. The manufacturer cut-off for FC positivity was 50 μg/g, with a sensitivity of 100% and a specificity of 53.1%. The number of patients developing IBD was evaluated at the end of follow-up. Clinical and laboratory data collection was centralized and two experts statisticians performed the data analysis. Statistical analysis. All demographic, clinical, and laboratory data were collected and descriptive statistics, presented as mean value and standard deviation, were calculated using Microsoft ® Office Excel for Windows and ©2019 Minitabs, LLC for Windows. Chi-square test was used for categorical variables. FC test sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated. Bayes's theorem was used to calculate the 95% confidence interval (95%CI). Correlations were calculated using Spearman's correlation (rs). P values ≤ 0.05 were accepted as statistically significant. The median follow-up was 30 months.

Interventions

DIAGNOSTIC_TESTFecal calprotectin assay

FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.

Sponsors

Giulia Franchi,Department of Rheumatology, Hospital of Prato
CollaboratorUNKNOWN
Maurizio Benucci,S.Giovanni di Dio Hospital
CollaboratorUNKNOWN
Raffaele Scarpa, Rheumatology Unit, University of Naples Federico II, Naples
CollaboratorUNKNOWN
Francesco Caso, Rheumatology Unit, University of Naples Federico II, Naples
CollaboratorUNKNOWN
Rosario Foti,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
CollaboratorUNKNOWN
Antonio Carletto,Rheumatology Unit, AOUI, Verona.
CollaboratorUNKNOWN
Elisa Visalli,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
CollaboratorUNKNOWN
Laura Niccoli,Department of Rheumatology, Hospital of Prato
CollaboratorUNKNOWN
Hospital of Prato
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age \>18 years * absence of any abdominal symptoms or diarrhoea * non-steroidal anti-inflammatory drug (NSAIDs) interruption 10 days before enrollment * Corticosteroids (CS) at stable low dose (prednisone 10 mg/day or equivalent) during the preceding 2 weeks were permitted in both groups.

Exclusion criteria

* age \< 18 years * previous diagnosis of CD or UC or current diagnosis of infectious colitis * previous therapy with traditional DMARDs or any biologic therapies * CS at high doses.

Design outcomes

Primary

MeasureTime frameDescription
The percentage of elevated FC levels in cases and controls3 YEARSComparison of FC levels between cases and controls

Secondary

MeasureTime frameDescription
Correlations of FC levels with laboratory data3 YEARSSpearman's correlation (rs)
The percentage of patients developing IBD over the follow up3 YEARSThe occurrence of IBD over the follow up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026