Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC

NCT06197308 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: MED-2023-32551
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• To evaluate safety of MTT in patients with PSC

  Determine the frequency of serious adverse events and other adverse events

  221 days

• To evaluate feasibility of MTT in patients with PSC

  Determine proportion of subjects taking 100% of the MTT per protocol.

  221 days

Study Arms (1)

PCS patients

EXPERIMENTAL

Drug: oral vancomycin and oral amoxicillin

Interventions

oral vancomycin and oral amoxicillin DRUG

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.

PCS patients

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 therapy and/or probiotic)
• 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

You may not qualify 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 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Vancomycin; Amoxicillin

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elizabeth Aby

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Kabage

CONTACT

kabage@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients with PSC

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)