Phase 2
N=10
Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
Sclerosing Cholangitis
Bottom Line
View on ClinicalTrials.gov: NCT02424175 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Aug 2019
Primary outcome: Primary: Adverse Event Frequency — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fecal Microbiota Transplantation (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event Frequency |
8 | — |
| PRIMARY Comparison of Alkaline Phosphatase Pre and Post Transplant |
3 | — |
| SECONDARY Microbiome |
8 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 20mg/day
Data sourced from ClinicalTrials.gov (NCT02424175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.