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Terminated NCT07653750

Study on Variation of Serum and Fecal Biomarkers After Treatment to Predict Mucosal Healing in Patients With Ulcerative Colitis

Conditions: Moderate to Severe Ulcerative Colitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 62
Sponsor: University Hospital, Clermont-Ferrand

Location: CHU de Clermont-Ferrand Clermont-Ferrand Auvergne

Summary

Mucosal healing is recognized hitherto as the best therapeutic endpoint in patients with Ulcerative Colitis (UC) but its use in daily practice is limited by the low acceptability of repeated colonoscopies. In this context, fecal biomarkers are attractive alternatives. Fecal calprotectin showed very good negative predictive value to eliminate IBD diagnosis, good correlation to endoscopic activity and good ability to predict relapse. Recently, several teams including ours, showed that fecal biomarkers such as Chitinase 3-Like 1 (CHI3L1), matrix metalloprotease type 9 (MMP-9) and serum biomarkers neutrophil gelatinase B- complex associated lipocalin (NGAL)-MMP9 and serum CHI3L1 could be better biomarkers than fecal calprotectin to assess endoscopic activity in patients with UC.

Eligibility Criteria

Inclusion Criteria: * Patients with Ulcerative Colitis * Age ≥ 18 years * Presence of endoscopic activity (Mayo endoscopic score ≥ 2) requiring the introduction, increase or change of treatment * Patients able to consent Non Inclusion Criteria : * Patients not affiliated to the social security system * Pregnant or breastfeeding woman * Patients who have total coloproctectomy with ileo-anal anastomosis * Acute Severe Ulcerative Colitis (ASUC) * Persons under guardianship, trusteeship or imprisonment Exclusion Criteria: * Patient wishing to discontinue participation in the study for any reason * Study exit at the investigator's discretion * Pregnancy Discovery

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07653750). StuddyBuddy aggregates publicly available trial information.