Clinical Trial: Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

Brief Summary: This is an open-label single-arm pilot study to measure the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2 who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use

Detailed Summary:
Sponsor: Brigham and Women's Hospital

Current Primary Outcome:

  • Comparison of microbiome pre and post transplant [ Time Frame: 12 weeks ]
    The investigators will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. The investigators will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
  • Comparison of liver biochemistries pre and post transplant [ Time Frame: 12 weeks ]
    The primary study end point is them mean change serum liver biochemistries after 3 months of treatment as compared with baseline. Treatment success was defined as an improvement in serum alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) by 50 % or greater.


Original Primary Outcome:

  • Comparison of microbiome pre and post transplant [ Time Frame: 12 weeks ]
    We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
  • Comparison of liver biochemistries pre and post transplant [ Time Frame: 12 weeks ]
    The primary study end point is them mean change serum liver biochemistries after 3 months of treatment as compared with baseline. Treatment success was defined as an improvement in serum alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) by 50 % or greater.


Current Secondary Outcome: Adverse event frequency [ Time Frame: 6 months ]

Number of patients with reporting adverse events with type and severity of adverse events reported


Original Secondary Outcome: Same as current

Information By: Brigham and Women's Hospital

Dates:
Date Received: April 18, 2015
Date Started: January 2016
Date Completion: December 2017
Last Updated: April 5, 2017
Last Verified: September 2016