Faecal microbiota transplantation for primary sclerosing cholangitis

Phase 1

• Conditions: primary sclerosing cholangitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12624000467538
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Diagnosis of PSC (small and large-duct) established for 6 months or more
2.Age 16-75 years
3.If taking ursodeoxycholic acid then stable dose at less than 25mg/kg/day for more than 12 weeks prior to study entry
4.Laboratory parameters:
oALP elevated above the upper limit of normal (above 110 U/L)
oInternational normalized ratio less than or equal to 1.3
oeGFR more than 60mL/min/1.73m2
oAlbumin more than 32 g/L
oPlatelets more than 120 x 109/

Exclusion Criteria

•Serum ALP variation > 30% between tests at two time-points 1 week apart during screening (unless both figures within normal range)
•Childs B or C cirrhosis (clinical parameters as assessed by the treating clinician) or clinically significant portal hypertension
•Total bilirubin > 1.5 x ULN unless due to Gilbert’s syndrome
•Liver transplantation
•Subtotal or total colectomy
•Active malignancy (cholangiocarcinoma or colorectal cancer)
•Presence of positive antimitochondrial antibody or features to suggest overlap autoimmune hepatitis
•Clinically significant dominant stricture deemed likely to require intervention within 3 months
•Ascending cholangitis within 3 months prior to enrolment
•Presence of a percutaneous drain or biliary stent
•Other causes of liver disease (alcohol induced hepatitis, viral hepatitis, primary biliary cholangitis, hemochromatosis, Wilson’s disease, Alpha-1 antitrypsin deficiency, non-alcoholic fatty liver disease)
•Pregnant or intending to become pregnant within 24 weeks
•Currently breastfeeding
•Immunodeficiency (beyond that associated with IBD-related therapy)
•Prebiotic, probiotic or antibiotic use within 4 weeks of enrolment
•Allergy or intolerance to vancomycin, metronidazole or neomycin
•Corticosteroid therapy of prednisolone >25mg daily (or equivalent)
•Anticoagulant therapy or dual antiplatelet therapy
•Active illicit drug use, narcotic drug use or alcohol consumption of a dependent nature
•Active IBD which has required change in therapy in the last 3 months or thought to require change in medication or surgery within 3 months of study entry
•Any medical condition that the treating gastroenterologist deems to pose a theoretical risk to the participant undergoing FMT
•Past colonic dysplasia apart from low grade dysplasia arising in tubular adenoma or sessile serrated adenoma
•Presence of IgG4-related disease
•Anaphylaxis to any food products
•Coeliac disease
•Participant unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified