EURECA (EUropeanRElapseCAlprotectin) Study

The study is prospective with a longitudinal approach. About 200 patients will be followed every 3 to 12 months (at basal, 3, 6, 9 and 12 months alternating visits to telephone contacts) and subsequently for further 6 months in 3 different sites (competitive enrollment, 1site/country, Italy, France and Spain respectively). Fecal samples for immunoassays will be collected at follow up visits, stored frozen (-20°C) and sent to testing lab for their determination.

The following assessments are foreseen:

Clinical history and demography (screening), Proctosigmoidoscopy (basal), Hemochromo with WBC differential count, C-reactive protein (every 6 months from screening up to 12 months; relapse), Coagulation (screening) Specimen collection for fecal calprotectin determination (within 1-2 weeks from Informed Consent signature; for basal time point; every next 3 months from basal up to 12 months and at month 18; relapse), Coproculture for Salmonella, Shigella, E. Coli and Campylobacter (relapse), Pharmacological ongoing therapy, Mayo score (each time point; relapse)

Inclusion criteria

• Adults,18 years and older, either genders
• Subject previously diagnosed with left-sided colitis or pancolitis based on endoscopy and, if available, confirmed by histological examination of biopsy taken during endoscopy
• Subject in clinical and endoscopic remission. Remission will be documented by proctosigmoidoscopy.
• Subject who may receive maintenance therapy as per current medical practice, e.g. mesalazine, corticosteroids, azathioprine, anti-TNF
• Availability of stool specimen for basal time point
• Subject willing and able to sign, the approved Informed Consent Form for this project in accordance with international and national regulations
• Subject able to understand and follow study procedures

Exclusion criteria

• Any subject that does not meet the inclusion criteria
• Subject with microscopic colitis
• Subject with Crohn's disease
• Subject with limited proctitis
• Subject with severe chronic disease affecting the possibility to comply with the study protocol (i.e. severe cardiovascular disease, renal or liver failure, neurologic disease, hematological disease and mental disorder)
• Subject who is regularly taking oral anticoagulants
• Subject who is currently pregnant or lactating
• Subject unable or unwilling to subscribe informed consent
• Subject unable or unwilling to perform required study procedures