Status:
UNKNOWN
A Systems Biology Approach for Identification of Host and Microbial Mechanisms and Druggable Targets for the Treatment of PSC-IBD
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Conditions:
Inflammatory Bowel Diseases
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18+ years
Brief Summary
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). Although rare, PSC is associated with significant and disproportionate unmet need...
Detailed Description
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). Although rare, PSC is associated with significant and disproportionate unmet need...
Eligibility Criteria
Inclusion
- Patients with confirmed diagnosis of primary sclerosing cholangitis and concurrent colitis
- Mild to moderately active colitis based on partial Mayo score of ≥3 and ≤6
- Scheduled for a standard of care lower GI endoscopy as part of disease assessment / surveillance
Exclusion
- History of previous colectomy
- Isolated small bowel disease
- Stricturing , fistulating or perianal phenotype
- Use of antibiotics and/or probiotics in the prior 3 months
- Use of steroids in last 2 weeks
- Commenced thiopurines / methotrexate in last 3 months
- History of intolerance to oral vancomycin
- Decompensated liver disease (Child C cirrhosis)
- Active infectious diarrhoea
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05376228
Start Date
February 1 2022
End Date
April 1 2023
Last Update
June 1 2022
Active Locations (1)
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1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW