Status:
UNKNOWN
Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Tel Aviv University
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often deb...
Detailed Description
All patients will undergo comprehensive screening by the bio-MDT. Aim 1: Antibiotic treatment- (patients with active disease) will be randomized to receive a prescription for one of two antibiotic re...
Eligibility Criteria
Inclusion
- Patients are able and willing to sign an informed consent
- Patients with UC who underwent pouch surgery and have a functioning pouch
- Disease activity (PDAI and PGA) according to study arm 1-3 inclusion
Exclusion
- Patients with ileostomy
- Significant comorbidity that precludes the patient from participating according to the physicians' judgment
- Non-Hebrew readers
- Pregnant and lactating women
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 11 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04082559
Start Date
June 11 2019
End Date
June 11 2023
Last Update
October 8 2020
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel