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New treatment option for Primary Sclerosing Cholangitis
Official title Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
ClinicalTrials.gov ID: NCT06197308
What this study is testing
What is oral vancomycin and oral amoxicillin?
oral vancomycin and oral amoxicillin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 76
You may be able to join if
- 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...
- 3-month washout period of obeticholic acid or other experimental therapies for PSC
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 76 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.