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

Launched by UNIVERSITY OF MINNESOTA · Dec 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for people with a liver condition called primary sclerosing cholangitis (PSC). The study will test the safety and feasibility of a therapy that involves transplanting beneficial bacteria from the mouth to see if it can help manage PSC symptoms. The trial is currently recruiting participants aged 18 to 76 who have been diagnosed with PSC for at least six months and meet certain health criteria, such as not having serious complications or other liver diseases.

Participants in the trial will need to continue their current medications and will be monitored closely throughout the study. They will have regular follow-ups through various means like phone calls or in-person visits. This trial is an early step to learn more about this treatment, and depending on the results, it could pave the way for larger studies in the future. If you're interested and think you might qualify, you can reach out to the research team for more information.

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Eligibility criteria

• Inclusion Criteria:
• • 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)
• • 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
• • Total colectomy