Pragmatic randomised controlled study to assess the effectiveness of two patient management strategies in mild-to-moderate Ulcerative Colitis - Ferring Optimise

Ferring0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

暂无简介。

•1) Adult Patients ( >= 18 years old at Baseline)
•2) Active Mild-to-moderate Ulcerative Colitis patients defined with:
•a. Rectal bleeding (RB) subscore >= 1 at Baseline, and
•b. Mayo endoscopic subscore >= 1, and
•c. Total of [RB + SF + Mayo endoscopic subscore] between 2 and 6.
•3) Patients who were on 5-ASA <= 2.4 g/day, or no Treatment regimen at Baseline
•escalating the therapy)
•4) Patients who are willing to use Faecal Calprotectin Home Test
•5) Patients with internet access and smartphone with camera
•6) Patients who have received adequate information regarding the study, and are
•understand and voluntarily sign the Informed Consent Form before any
•study-related
•procedures.

•1) Patients with contra-indications to 5-ASA and/or 2nd generation
•corticosteroids as per
•2) Patients currently on Nonsteroidal anti-inflammatory drug (NSAID) and
•Proton-pump
•inhibitor (PPI) treatment as they affect FC levels
•3) Patients exposed to immunosuppressants and/or biologics within 6 months
•4) Patients with positive stool culture up to 2-weeks prior Baseline (bacterial
•pathogens -
•SSYC, Clostridium Difficile, toxinC, ova and parasites) having received no
•treatment to treat infection
•5) Patients not willing to perform FC self-monitoring at home
•6) Patients not willing to undergo a flexible sigmoidoscopy/colonoscopy at the
•end of study
•7) Patients currently enrolled in another interventional study
•8) Pregnant/breastfeeding woman
•9) Known mental incapacity or language barriers precluding adequate
•understanding of the
•Informed Consent information and the study activities
•10) Inability by the judgement of the investigator to participate in the study
•for other reasons.

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