← Back to Search

Microbiota-based Therapy

PCS patients for Primary Sclerosing Cholangitis

Phase < 1

Recruiting

Led By Elizabeth Aby

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PSC based on American Association for the Study of Liver Diseases2: serum alkaline phosphatase (ALP) ≥ 1.5x upper limit of normal, cholangiographic evidence for PSC per MRI, endoscopic retrograde cholangiopancreatography, direct cholangiography or liver biopsy for > 6 months in duration

Ages 18-76

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 221 days

Awards & highlights

Study Summary

This trial will test a new treatment called microbiota transplant therapy (MTT) in patients with primary sclerosing cholangitis (PSC) to see if it is safe and effective. The

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, common ones associated with antibiotics like vancomycin and amoxicillin include digestive upset, allergic reactions, rash, and in some cases more serious effects such as antibiotic-resistant infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PSC and have high ALP levels or imaging/biopsy evidence for over 6 months.

Select...

I am between 18 and 76 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 221 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~221 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 221 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate feasibility of MTT in patients with PSC

To evaluate safety of MTT in patients with PSC

Trial Design

1Treatment groups

Experimental Treatment

Group I: PCS patientsExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,551,256 Total Patients Enrolled

Elizabeth AbyPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"As per the information provided on clinicaltrials.gov, this specific clinical trial is not presently seeking participants. The study was initially posted on January 1st, 2024 and underwent its most recent update on December 26th, 2023. Although this particular study is inactive in terms of patient recruitment, it's worth noting that there are currently 53 alternative studies actively enrolling individuals at present."

Answered by AI

Is the inclusion criteria for this medical study limited to individuals below the age of 65?

"To be considered eligible for this trial, individuals must fall within the age range of 18 to 76. It is worth noting that there are separate clinical trials available for participants under the age of 18 (6 trials) and those over the age of 65 (51 trials)."

Answered by AI

Is it possible for me to participate in this clinical trial?

"To qualify for participation in this clinical trial, potential candidates need to have a diagnosis of primary sclerosing cholangitis and fall within the age range of 18 to 76 years. A total of 28 individuals will be accepted into the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06197308.

All > Paid Studies Minneapolis