Using oral microbiota therapy to treat primary sclerosing cholangitis
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis
This study is testing a new treatment using oral antibiotics to see if it can help people with primary sclerosing cholangitis feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 76 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06197308 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the safety and feasibility of microbiota transplant therapy (MTT) in patients diagnosed with primary sclerosing cholangitis (PSC). Participants will receive oral vancomycin and oral amoxicillin as part of the treatment regimen. The study will assess the initial responses to this therapy, which could inform the design of larger future trials targeting PSC. The trial will include a follow-up period to monitor patient outcomes and adherence to treatment protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-76 with a diagnosis of primary sclerosing cholangitis who meet specific health criteria.
Not a fit: Patients with advanced complications of PSC or those currently on other antibiotic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients suffering from primary sclerosing cholangitis.
How similar studies have performed: While this approach is novel, similar microbiota-based therapies have shown promise in other conditions, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Aby — University of Minnesota
- Study coordinator: Amanda Kabage
- Email: kabage@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.