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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197308
Other study ID # MED-2023-32551
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date September 1, 2025

Study information

Verified date March 2024
Source University of Minnesota
Contact Amanda Kabage
Email kabage@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date September 1, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility Inclusion Criteria: - Ages 18-76 - Diagnosis of PSC based on American Association for the Study of Liver Diseases2: serum alkaline phosphatase (ALP) = 1.5x upper limit of normal, cholangiographic evidence for PSC per MRI, endoscopic retrograde cholangiopancreatography, direct cholangiography or liver biopsy for > 6 months in duration - Serum total bilirubin at screening = 2x the upper limit of normal - Absence of biliary obstruction and malignancy by ultrasound or equivalent imaging within 6 months of study entry - Anticipated maintenance of current medication regimen through the treatment period (UDCA, azathioprine, corticosteroid, methotrexate, 5-ASA, biologic therapy and/or probiotic) - 3-month washout period of obeticholic acid or other experimental therapies for PSC - Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence. - Informed consent Exclusion Criteria: - Antibiotic therapy (except vancomycin) within 3 months or anticipated antibiotic use in the course of the MTT treatment - Presence of complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome - Evidence for viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS - Metabolic or inherited liver disease (e.g., Wilson's, hemochromatosis, alpha-1-antitrypsin deficiency) - Another disease involving bile ducts (e.g., primary biliary cholangitis, IgG4-related cholangitis, secondary sclerosing cholangitis) - Evidence of cirrhosis on the last magnetic resonance cholangiopancreatography (within 6 months) - Pregnancy or attempting to become pregnant or breastfeeding. - History of liver transplantation, anticipated need for liver transplantation within 12- months from randomization, or a Model of End Stage Liver Disease (MELD) score of =15 - Active malignancy - Active alcohol overuse (>4 drinks per day for men, and >2 drinks per day for women) - Moderate-to-severe renal impairment with a calculated creatinine clearance of < 45 mL/min - Neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L) - History of allergic reaction to vancomycin - History of allergic reaction to amoxicillin or other beta-lactam antibiotics - Any other conditions or abnormalities that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study

Study Design


Intervention

Drug:
oral vancomycin and oral amoxicillin
In this study, PSC patients will receive an antibiotic preconditioning regimen of oral vancomycin (500 mg liquid twice a day) for 28 days and oral amoxicillin (1000 mg twice a day) for 7 days (during the last 7 days of the oral vancomycin). Following vancomycin and amoxicillin, encapsulated, freeze-dried microbiota preparation (MTP-101C) will be administered - dosed at = 5 x 10^11 bacteria (five capsules) daily for 3 days followed by = 2 x 10^11 bacteria (two capsules) for 11 days - for a total of 14 days of MTP-101C; total of 37 capsules.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate safety of MTT in patients with PSC Determine the frequency of serious adverse events and other adverse events 221 days
Primary To evaluate feasibility of MTT in patients with PSC Determine proportion of subjects taking 100% of the MTT per protocol. 221 days
See also
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Recruiting NCT01688024 - Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis Phase 2
Completed NCT03041662 - Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
Completed NCT05866809 - Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis Phase 2
Recruiting NCT05618145 - National Database on Primary Sclerosing Cholangitis (PSC)
Active, not recruiting NCT02446665 - Disease Status in Primary Sclerosing Cholangitis by Elastography N/A
Completed NCT02247934 - Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC) N/A
Completed NCT01088607 - Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis Phase 1
Terminated NCT01142323 - Pilot Study of Fenofibrate for PSC Phase 1/Phase 2
Terminated NCT04060147 - Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis Phase 1
Recruiting NCT04133792 - Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) Phase 3
Active, not recruiting NCT04595825 - CM-101 in PSC Patients -The SPRING Study Phase 2
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Completed NCT02943460 - Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis Phase 2
Completed NCT00951327 - Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP) N/A
Completed NCT04024813 - A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC Phase 2
Recruiting NCT05912387 - Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study Early Phase 1
Completed NCT02884557 - NKT Role in the Regulation of the Inflammatory Bowel Disease N/A