Skip to main content
MedPathMedPath Home
Clinical Trials/ACTRN12621000792820
ACTRN12621000792820
Recruiting
Phase 3

The impact of targeting the gut microbiome on improvement in liver function in individuals with Primary Sclerosing Cholangitis: The Queensland Clinical Network Study.

Princess Alexandra Hospital0 sites34 target enrollmentJune 23, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Princess Alexandra Hospital
Enrollment
34
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 23, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
The effect of modulating gut microflora on clinical outcome in elective surgical patients.
ISRCTN15806146Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)80
Completed
Phase 1
Assessment of the influence of the gut microbiome on tacrolimus pharmacokinetics in healthy volunteersPharmacokinetic trial in healthy volunteers
DRKS00032072niversitätsklinikum Heidelberg, Im Wege der Auftragsverwaltung für die Universität Heidelberg, Medizinische Fakultät Heidelberg20
Recruiting
Not Applicable
Predicting the impact of the gut microbiome on immunosuppressive drug metabolism in kidney transplant patientsKidney Transplantation
DRKS00023398niversitätsklinikum Heidelberg130
Not yet recruiting
Not Applicable
Exploratory study of the effect on gut microbiota by ingestion of oligosaccharide.Healthy adult
JPRN-UMIN000052735Meiji Co., Ltd.49
Completed
Not Applicable
Impact of intestinal microbiome on infections, course and outcome of haematological-oncological patients treated with chemotherapygut microbiomeC92.0Acute myeloblastic leukaemia [AML]
DRKS00011674niversitätsklinikum Magdeburg12