Expired Study
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Boston, Massachusetts 02115


Purpose:

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


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


NCT ID:

NCT02424175


Primary Contact:

Principal Investigator
Joshua Korzenik, MD
Brigham and Women's Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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