PSCRecruiting
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC
Early Phase 1 · Testing oral vancomycin and oral amoxicillin · 1 site · University of Minnesota
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing oral vancomycin and oral amoxicillin (a drug) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis.
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 76
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 28 participants are expected to take part.
- The study has 1 group.
- Start date: 2024-03-01.
- Main results expected around 2027-03-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- PCS patients (listed as: experimental group)
Main thing being measured
- To evaluate safety of MTT in patients with PSC (221 days)
- To evaluate feasibility of MTT in patients with PSC (221 days)
In the researchers’ words
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.
Words you might see
- ULN: upper limit of normal: the top of the usual range for a lab test.
- UDCA (ursodiol): a bile acid medicine that some people with PSC take.
- Bilirubin: a yellow substance measured in blood; high levels can be a sign of liver or bile-duct problems.
- MELD score: a score based on lab tests used to estimate how severe liver disease is.
- Cirrhosis: advanced scarring of the liver.
- Maintenance: longer-term treatment aimed at keeping the disease under control.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
- PBC: primary biliary cholangitis, a different chronic bile-duct disease.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis |
| Lead sponsor | University of Minnesota |
| Enrollment | 28 (estimated) |
| Start date | 2024-03-01 |
| Primary completion (est.) | 2027-03-31 |
| First posted | 2024-01-09 |
| Last updated | 2026-05-20 |
| Official title | Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis |
| ClinicalTrials.gov ID | NCT06197308 |
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 c…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota | Minneapolis, Minnesota | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.