Recruiting NCT06197308
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral vancomycin and oral amoxicillin.
- Who it may be relevant to
- Registry conditions: Primary Sclerosing Cholangitis. Basic parameters: 18 years — 76 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis
Overview
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.
Interventions
- Drug oral 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 tota
Primary outcome measures
- To evaluate safety of MTT in patients with PSC [Time frame: 221 days]
- To evaluate feasibility of MTT in patients with PSC [Time frame: 221 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06197308 · MED-2023-32551