A Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing Cholangitis

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    102
  • sponsor
    Elizabeth Carey
Updated on 17 September 2022
vancomycin
prednisone
cholangiography
MRI
liver disease
obstruction
ulcerative colitis
colitis
biliary obstruction
ursodiol
bowel disease
steroid compound

Summary

To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis.

Funding Source - FDA OOPD

Description

  1. Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6,12,and 18 months of OV treatment, and at 3, and 6 months post OV treatment will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.
  2. Determine if OV stabilizes or improves liver fibrosis assessed by LSM using TE. Liver stiffness will be measured at 6, 12, and 18 months of OV treatment, and at 6 months post OV treatment, and values will be compared to those obtained at baseline (month 0), and with values in the placebo arm.
  3. Determine the changes in the intestinal microbiota in relation to the use of OV, and study the correlation between the changes in the intestinal microbiota and the changes in: 1) liver enzymes, particularly serum ALP, and 2) liver stiffness, assessed by LSM using TE.
  4. Determine if changes in proinflammatory cytokines (TGF-β, IL-4, IL-13, IL-10, etc.) predict response to OV. Cytokines will be measured at baseline, months 6, 12, 18, and at 3, and 6 months post OV treatment, if the study is positive.

Details
Condition Primary Sclerosing Cholangitis
Treatment Placebo, Vancomycin
Clinical Study IdentifierNCT03710122
SponsorElizabeth Carey
Last Modified on17 September 2022

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