Inflammatory Bowel Diseases Remission Registry

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Jun 2, 2021

Keywords

ClinConnect Summary

The Inflammatory Bowel Diseases Remission Registry is a clinical trial aimed at understanding factors that may influence the flare-ups of Crohn's disease, ulcerative colitis, and pouchitis. These conditions can cause long-term inflammation in the gut, leading to symptoms like abdominal pain and diarrhea. The study is particularly interested in how factors such as sleep quality and daily routines might affect these diseases. While many patients can achieve periods of symptom relief (remission), about 30-40% may experience a relapse within six months. Researchers want to find out more about these relapses to help improve treatment and prevention strategies.

To be eligible for this study, participants must be between 18 and 80 years old and have been diagnosed with Crohn's disease, ulcerative colitis, or pouchitis for at least two months. They should be in a stable state of remission without needing steroid therapy recently. Participants will engage in a variety of assessments related to their health and lifestyle. This study is important because it may help uncover valuable insights into managing these conditions better, ultimately improving the quality of life for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed as suffering from Crohn's disease (CD), Ulcerative colitis (UC) or Pouchitis for at least 2 months who are in clinical and biologic remission according to Steroid free clinical remission for greater or equal to 3 months according to the following activity index
• • Harvey Bradshaw index (HBI)\<5 for CD patients
• • Simple Clinical Colitis activity index (SCCAI)≤2 for UC patients
• • Pouch disease activity index ≤6 / mPDAI ≤4 for Pouch patients
• Also, patients will be included if they fullfull the following:
• • Age 18-80 years
• • Clinically stable patients, on constant medicinal regimen (mesalamine at least 4 weeks, or immunomodulators at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before inclusion to the study)
• Exclusion Criteria:
• • • Inability to sign an informed consent and complete the study protocol
• • Steroid therapy during the past 3 months
• • Antibiotic therapy during the past 2 weeks
• • Unstable or uncontrolled medical disorder, and sever systemic disease (other than IBD)
• • Participating in another clinical interventional trial
• • Stoma