RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06197308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 76 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Amanda Kabage

CONTACT

kabage@umn.edu

Principal Investigator

Elizabeth Aby

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Elizabeth Aby, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

Primary Sclerosing Cholangitis