Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.



Status:Completed
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:January 2016
End Date:July 2018

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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


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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-6389
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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