Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy

Launched by RESILIENCE · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people with inflammatory bowel disease (IBD), which includes conditions like Crohn’s disease and ulcerative colitis. The study is comparing regular care to a special mobile app called GutyCare. This app allows patients to report their symptoms remotely, and if any serious problems are detected, it sends an alert to their healthcare team. This way, doctors can quickly adjust treatments to better manage the disease. The goal is to see if using this app can improve overall care without making health outcomes worse.

People who might join this study are adults with IBD who have had the disease for at least three months and are starting or changing to a new advanced treatment, such as biologic medicines. Participants should have active symptoms but not have had major bowel surgery or other serious related complications. If they agree to join, they will either continue with their usual care or use the GutyCare app to report symptoms regularly. This study is not yet recruiting, but it aims to find out if technology like this can make managing IBD easier and more effective for patients and their care teams.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before enrolment
• • Initiating an advanced therapy (i.e., biologic therapy or small molecule) OR occurrence of a substantial change in the treatment of the disease.
• • Active disease.
• Exclusion Criteria:
• • Patients with altered intestinal continuity or function due to major abdominal surgery (e.g., stoma, extensive resection, anastomosis), uncontrolled intra-abdominal abscess, or active perianal disease.
• • Patients for whom digestive surgery is expected during the study period.
• • Patients unable or unwilling to use or already using GutyCare.
• • Vulnerable individuals as defined by French law.