Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)

Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis

The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (FC) (substance that is released when intestines are inflamed and that can be measured in faeces), can provide significantly higher benefit for the participants in terms of disease control and quality of life (QoL) improvement, compared to a symptom-based approach only.

Inclusion Criteria:

• Adult Participants (≥ 18 years old)
• Participants with active mild-to-moderate UC (with RB and bowel inflammation confirmed by endoscopy)
• Participants with treatment with 5-aminosalicylic acid (5-ASA) ≤ 2.4 g/day or with no treatment regimen at Baseline
• Participants who agree to use FC home test (to dose FC in faeces as a marker of inflammation)
• Participants with internet access and smartphone with camera

Exclusion Criteria:

• Participants currently enrolled in another interventional study
• Participants not willing to undergo an endoscopy at the end of study
• Participants with contraindications to treatment with 5-ASA and/or 2nd generation corticosteroids
• Participants not willing to perform FC self-testing in faeces at home