Targeting the gut microbiome as a treatment for Primary Sclerosing Cholangitis: The Queensland Clinical Network Study

Phase 3

Recruiting

• Conditions: Primary Sclerosing Cholangitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000792820
• Lead Sponsor: Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

•Male and females (females of childbearing age must have negative pregnancy test within 48 hours of participation and agreement to practice contraception for the duration of the study), age =>14 years old and <75 years,
0 Established clinical diagnosis of PSC (confirmed by a hepatologist) with or without an associated IBD
oHistory of chronic cholestatic disease of at least 6 months duration,
oSerum alkaline phosphatase level at least 1.5 times the upper limit of normal.
oCholangiography or MRCP demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC (without evidence for other causes of the biliary abnormalities).
0 Patients have given informed consent for study participation.
0 All other treatments for PSC and IBD need to be stable for the last 4 weeks prior to inclusion.

Exclusion Criteria

•Findings highly suggestive of hepatobiliary disease of other aetiology complicating PSC,
•Anticipated need for liver transplantation in one year (e.g. determined by Mayo model with an estimate of <75% one year survival without transplantation),
•Recurrent variceal bleeding, presence of ascites, or encephalopathy,
•Active drug or alcohol use, pregnancy, breast feeding,
•Serum creatinine over 1.5 fold of the norm,
•Prior history of allergic reactions to antibiotics belonging to the family to be used,
•Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
•Evidence of active malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of ALP as assessed with blood test.[ At baseline and after 12 weeks of treatment.]