Could a fecal transplant help treat a rare liver disease?
NCT ID NCT06197308
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a transplant of healthy gut bacteria can be safely given to people with primary sclerosing cholangitis (PSC), a rare liver disease. Twenty-eight adults will first take antibiotics to clear their gut, then receive capsules containing freeze-dried bacteria. The goal is to see if the approach is safe and feasible, not yet whether it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral vancomycin, oral amoxicillin, and a freeze-dried microbiota preparation (MTP-101C)
- What this could lead to
- If it works, this could point toward a new way to manage primary sclerosing cholangitis by restoring gut bacteria balance.
- What could go wrong
- This is a very early, small pilot study (28 people) testing only safety and feasibility, not effectiveness. The treatment involves strong antibiotics and a live bacterial product, which may cause side effects or fail to show benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 76 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55414, United States
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