Primary Sclerosing CholangitisEarly Phase 1NCT06197308
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
A Early Phase 1 study testing oral vancomycin and oral amoxicillin in people with Primary Sclerosing Cholangitis, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- oral vancomycin and oral amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Sep 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Kabage contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Amanda Kabage, kabage@umn.edu
About this study
Official title: Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis
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.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- oral vancomycin and oral amoxicillin
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral vancomycin and oral amoxicillinDrug
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 total of 14 days of MTP-101C; total of 37 capsules.
| Study group | Role | What they receive |
|---|---|---|
| PCS patients | Experimental | Not described Receives: Drug: oral vancomycin and oral amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety of MTT in patients with PSC
Determine the frequency of serious adverse events and other adverse events
Measured: 221 days
To evaluate feasibility of MTT in patients with PSC
Determine proportion of subjects taking 100% of the MTT per protocol.
Measured: 221 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients with PSC
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Aby, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197308
- Sponsor's protocol ID
- MED-2023-32551
- Status last verified
- May 2026
- First submitted
- 26 Dec 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No