Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

Completed · Phase 1/Phase 2

Conditions studied: Sclerosing Cholangitis

In brief

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

Key facts

Study ID

NCT02424175

Run by

Brigham and Women's Hospital

People needed

10

Starts

2016-02-01

Expected to finish

2018-05-08

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• 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.

You may not qualify if…

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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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