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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06197308
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PCS patients

Primary Outcome Measure

To evaluate safety of MTT in patients with PSC [ Time Frame: 221 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Amanda Kabage
[email protected]

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By research site
University of Minnesota· Minneapolis, MN

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