Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02424175
Recruitment Status : Active, not recruiting
First Posted : April 22, 2015
Last Update Posted : October 9, 2017
Information provided by (Responsible Party):
Joshua Korzenik, Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
Sclerosing Cholangitis Biological: Fecal Microbiota Transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Patients with PSC
This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.
Biological: Fecal Microbiota Transplantation

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Adverse event frequency [ Time Frame: 6 months ]
    Number of patients with reporting adverse events with type and severity of adverse events reported

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 or older
  2. Confirmed diagnosis of PSC (with a concurrent diagnosis of inflammatory bowel disease) characterized by a cholestatic liver condition of greater than 6 months duration with confirmatory cholangiographic findings, as well as an elevation of the serum alkaline phosphatase of greater than 1.5 times the upper limit of normal.

Exclusion Criteria:

  1. Decompensated liver disease
  2. Patients who were pregnant or breastfeeding
  3. Use of concomitant immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11 within 4 weeks prior to receiving the FMT
  4. Patients who are unable to give informed consent
  5. Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)
  6. Patients who have previously undergone FMT Patients who have a confirmed malignancy or cancer
  7. Patients who are immunocompromised
  8. Treatment within last 8 weeks with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide
  9. Antibiotic use within 2-months of start date
  10. Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
  11. Probiotic use within 30 days of start date
  12. Congenital or acquired immunodeficiencies
  13. Other comorbidities including:Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
  14. Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
  15. History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia from colonoscopy
  16. Steroid dose >20mg/day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02424175

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Joshua Korzenik, MD Brigham and Women's Hospital

Responsible Party: Joshua Korzenik, Director, Crohn's and Colitis Center, Brigham and Women's Hospital Identifier: NCT02424175     History of Changes
Other Study ID Numbers: 2014P002475
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: September 2016

Keywords provided by Joshua Korzenik, Brigham and Women's Hospital:
Fecal Transplant
Primary Sclerosing Cholangitis
Fecal Microbiota Transplantation

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases