28 Participants Needed

Microbiota Transplant Therapy for Sclerosing Cholangitis

AK
Overseen ByAmanda Kabage
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Minnesota
Must be taking: UDCA, azathioprine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You can continue taking your current medications during the trial, except for obeticholic acid or other experimental therapies for PSC, which require a 3-month break before starting the trial.

Is Microbiota Transplant Therapy safe for humans?

A study found that fecal microbiota transplant (FMT) was safe for patients with primary sclerosing cholangitis (PSC) and inflammatory bowel disease in remission, showing stable microbial diversity and donor engraftment without significant adverse effects.12345

How is Microbiota Transplant Therapy different from other treatments for sclerosing cholangitis?

Microbiota Transplant Therapy is unique because it involves transferring healthy bacteria from a donor to the patient's gut, aiming to restore the balance of gut bacteria and improve liver health. Unlike traditional treatments, this approach targets the gut-liver connection and has shown potential in altering liver biochemistry and microbial diversity, offering a novel way to manage sclerosing cholangitis, which currently lacks effective medical therapies.12367

What data supports the effectiveness of the treatment Oral Microbiota-based Therapeutic for Sclerosing Cholangitis?

A case report showed that transplanting healthy donor fecal microbiota (the community of bacteria in the gut) helped improve liver function and reduce recurrent bacterial infections in a patient with primary sclerosing cholangitis, suggesting potential benefits of microbiota-based treatments.23578

Who Is on the Research Team?

EA

Elizabeth Aby

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals with primary sclerosing cholangitis (PSC), a liver condition affecting the bile ducts. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

I have been diagnosed with PSC and have high ALP levels or imaging/biopsy evidence for over 6 months.
My recent scans show no blockage or cancer in my bile ducts.
I am willing and able to follow all study procedures and be available for the entire trial.
See 4 more

Exclusion Criteria

Pregnancy or attempting to become pregnant or breastfeeding
Neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L)
History of allergic reaction to amoxicillin or other beta-lactam antibiotics
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microbiota transplant therapy (MTT) to evaluate initial safety and feasibility

31 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Oral Microbiota-based Therapeutic
Trial Overview The trial is testing oral vancomycin and oral amoxicillin as part of microbiota transplant therapy (MTT) for PSC. It aims to assess the safety and feasibility of MTT to inform future larger-scale trials targeting this liver condition.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: PCS patientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Published Research Related to This Trial

Germ-free mdr2-/- mice experienced 100% mortality within 8 weeks due to liver disease, but autologous stool transplantation from SPF mice significantly improved survival, highlighting the critical role of gut microbiota in liver health.
Specific bacterial families, such as Lachnospiraceae, were found to be protective against liver fibrosis and inflammation in PSC patients, while others like Enterococcus faecalis were associated with worse clinical outcomes, suggesting potential for targeted microbiome-based therapies.
Protective and aggressive bacterial subsets and metabolites modify hepatobiliary inflammation and fibrosis in a murine model of PSC.Awoniyi, M., Wang, J., Ngo, B., et al.[2023]
This study presents the first successful use of healthy donor fecal transplantation to treat recurrent acute bacterial cholangitis in a patient with primary sclerosing cholangitis, highlighting a novel therapeutic approach.
Following the fecal transplantation, significant improvements were observed in liver biochemistry, bile acid levels, and the bacterial community in the patient's gut, suggesting a positive impact on managing cholangitis symptoms.
Healthy Donor Fecal Microbiota Transplantation for Recurrent Bacterial Cholangitis in Primary Sclerosing Cholangitis - A Single Case Report.Philips, CA., Augustine, P., Phadke, N.[2020]
Patients with primary sclerosing cholangitis (PSC) exhibit a distinct microbiome in their bile ducts compared to healthy controls, characterized by reduced biodiversity and an increase in the pathogen Enterococcus faecalis.
The presence of Enterococcus faecalis in the bile ducts is strongly correlated with higher levels of the harmful secondary bile acid taurolithocholic acid, which may contribute to inflammation and cancer risk in PSC patients.
Alterations of the bile microbiome in primary sclerosing cholangitis.Liwinski, T., Zenouzi, R., John, C., et al.[2020]

Citations

Protective and aggressive bacterial subsets and metabolites modify hepatobiliary inflammation and fibrosis in a murine model of PSC. [2023]
Healthy Donor Fecal Microbiota Transplantation for Recurrent Bacterial Cholangitis in Primary Sclerosing Cholangitis - A Single Case Report. [2020]
Alterations of the bile microbiome in primary sclerosing cholangitis. [2020]
Distinct gut microbiota profiles in patients with primary sclerosing cholangitis and ulcerative colitis. [2018]
The features of mucosa-associated microbiota in primary sclerosing cholangitis. [2022]
Manipulation of the Gut-Liver Axis Using Microbiome Restoration Therapy in Primary Sclerosing Cholangitis. [2020]
A shared mucosal gut microbiota signature in primary sclerosing cholangitis before and after liver transplantation. [2023]
Fecal Microbiota Transplantation in Patients With Primary Sclerosing Cholangitis: A Pilot Clinical Trial. [2021]
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