Advanced Therapy Registry of IBD Patients

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Aug 9, 2021

Keywords

ClinConnect Summary

The Advanced Therapy Registry of IBD Patients is a clinical trial that aims to study the gut bacteria and other factors that may influence the health of patients with inflammatory bowel disease (IBD), specifically Crohn's disease, ulcerative colitis, and pouchitis. Researchers want to understand how these factors change during diagnosis and treatment with biological therapies, which are medications designed to help manage these conditions. The trial is currently recruiting participants of all genders, ages 6 to 93, who fall into specific groups, such as those newly diagnosed with IBD, those in remission, or those starting biological therapy.

To join the study, participants must be at least 6 years old and meet certain criteria, like having a new IBD diagnosis or being in remission. However, there are some people who cannot participate, such as those under 18, those who have had recent abdominal surgery, or those with certain serious health conditions. If someone is eligible and decides to join, they can expect to provide information about their health and possibly provide samples to help researchers learn more about the disease. This study is important as it could lead to better treatment options and a deeper understanding of IBD for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients who belong to one of the following sub-groups:
• • 1. Newly diagnosed (\<1 years), therapy naïve IBD and pouchitis patients
• • 2. IBD patients in complete remission (treated or untreated with biologics)
• • 3. Patients (with and without IBD) scheduled to commence a biological therapy
• Exclusion Criteria:
• • 1. Age≤18 years
• • 2. Inability to sign an informed consent
• • 3. Abdominal surgery during the previous 3 months
• • 4. Systemic antibiotic therapy in the previous 4 weeks
• • 5. Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease
• • 6. Primary sclerosing cholangitis
• • 7. Pregnancy at recruitment
• • 8. Cancer within the previous 5 years excluding local NMSC