Status:
RECRUITING
Inflammatory Bowel Diseases Remission Registry
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Brief Summary
The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pa...
Detailed Description
Prospectively follow IBD patients in remission (both clinical and biochemical) until disease exacerbation. • Specific aims: * To detect risk factors and early signs for disease exacerbation in IBD p...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04912999
Start Date
August 1 2019
End Date
May 1 2026
Last Update
May 16 2024
Active Locations (1)
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1
Tel Aviv Medical Center; ,
Tel Aviv, Israel, 64239