Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.
NCT ID: NCT04190108
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
259 participants
OBSERVATIONAL
2016-01-02
2019-10-31
Brief Summary
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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
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case patients
All consecutive, new patients older than 18 years with PsA (CASPAR criteria) at onset observed over 3-year period, who had any abdominal symptoms.
Fecal calprotectin assay
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.
Controls
All consecutive new patients meeting the ACR/EULAR 2010 classification criteria for rheumatoid arthritis (RA) at onset.
Fecal calprotectin assay
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.
Interventions
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Fecal calprotectin assay
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Giulia Franchi,Department of Rheumatology, Hospital of Prato
UNKNOWN
Maurizio Benucci,S.Giovanni di Dio Hospital
UNKNOWN
Raffaele Scarpa, Rheumatology Unit, University of Naples Federico II, Naples
UNKNOWN
Francesco Caso, Rheumatology Unit, University of Naples Federico II, Naples
UNKNOWN
Rosario Foti,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
UNKNOWN
Antonio Carletto,Rheumatology Unit, AOUI, Verona.
UNKNOWN
Elisa Visalli,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
UNKNOWN
Laura Niccoli,Department of Rheumatology, Hospital of Prato
UNKNOWN
Hospital of Prato
OTHER
Responsible Party
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Fabrizio Cantini
MD
Locations
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Fabrizio Cantini
Prato, Tuscany, Italy
Countries
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References
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Fu Y, Lee CH, Chi CC. Association of Psoriasis With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Dec 1;154(12):1417-1423. doi: 10.1001/jamadermatol.2018.3631.
Scher JU, Ubeda C, Artacho A, Attur M, Isaac S, Reddy SM, Marmon S, Neimann A, Brusca S, Patel T, Manasson J, Pamer EG, Littman DR, Abramson SB. Decreased bacterial diversity characterizes the altered gut microbiota in patients with psoriatic arthritis, resembling dysbiosis in inflammatory bowel disease. Arthritis Rheumatol. 2015 Jan;67(1):128-39. doi: 10.1002/art.38892.
Klingberg E, Strid H, Stahl A, Deminger A, Carlsten H, Ohman L, Forsblad-d'Elia H. A longitudinal study of fecal calprotectin and the development of inflammatory bowel disease in ankylosing spondylitis. Arthritis Res Ther. 2017 Feb 2;19(1):21. doi: 10.1186/s13075-017-1223-2.
Adarsh MB, Dogra S, Vaiphei K, Vaishnavi C, Sinha SK, Sharma A. Evaluation of subclinical gut inflammation using faecal calprotectin levels and colonic mucosal biopsy in patients with psoriasis and psoriatic arthritis. Br J Dermatol. 2019 Aug;181(2):401-402. doi: 10.1111/bjd.17745. Epub 2019 May 6. No abstract available.
Scarpa R, Manguso F, D'Arienzo A, D'Armiento FP, Astarita C, Mazzacca G, Ayala F. Microscopic inflammatory changes in colon of patients with both active psoriasis and psoriatic arthritis without bowel symptoms. J Rheumatol. 2000 May;27(5):1241-6.
Other Identifiers
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HPrato-2
Identifier Type: -
Identifier Source: org_study_id