Recruiting
Early Phase 1

Oral Microbiota

Sponsor:

University of Minnesota

Code:

NCT06197308

Conditions

Primary Sclerosing Cholangitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

oral vancomycin and oral amoxicillin

Study Details

Brief 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.

Conditions

Primary Sclerosing Cholangitis

Study ID

NCT06197308

Start date

Mar 1, 2024

Status verified date

May, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PCS patients

Interventions

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 total of 14 days of MTP-101C; total of 37 capsules.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amanda Kabage

kabage@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Amanda Kabage

kabage@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-20.