RecruitingEarly Phase 1NCT06197308

Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC

Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis

Sponsor

University of Minnesota

Enrollment

28 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Primary Sclerosing Cholangitis

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.

Eligibility

Min Age: 18 YearsMax Age: 76 Years

Inclusion Criteria7

Ages 18-76
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)
-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 Criteria16

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
Total colectomy

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Interventions

DRUGoral 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.