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Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

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ClinicalTrials.gov Identifier: NCT02424175
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : August 21, 2019
Last Update Posted : August 28, 2019
Sponsor:
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 safety, 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual 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.
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : May 8, 2018


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. Adverse Event Frequency [ Time Frame: 6 months ]
    Number of patients with reporting adverse events irregardless of severity

  2. Comparison of Alkaline Phosphatase Pre and Post Transplant [ Time Frame: Baseline and 6 months ]
    The primary clinical study end point is the number of patients that achieve a 50% or more decrease serum alkaline phosphatase


Secondary Outcome Measures :
  1. Microbiome [ Time Frame: 6 months ]
    Number of patients that experienced changes in the microbiome post FMT. Measured as similarity to the donor microbiome post FMT compared to their baseline sample



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

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 ClinicalTrials.gov identifier (NCT number): NCT02424175


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Joshua Korzenik, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Joshua Korzenik, Brigham and Women's Hospital:

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Responsible Party: Joshua Korzenik, Director, Crohn's and Colitis Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02424175     History of Changes
Other Study ID Numbers: 2014P002475
First Posted: April 22, 2015    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2018
Keywords provided by Joshua Korzenik, Brigham and Women's Hospital:
Fecal Transplant
Primary Sclerosing Cholangitis
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases