Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

NCT02424175 | Completed Phase 1 Results DMC

• 1 other identifier: 2014P002475
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Sclerosing Cholangitis

Keywords

Fecal Transplant; Primary Sclerosing Cholangitis; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (2)

• Adverse Event Frequency

  Number of patients with reporting adverse events irregardless of severity

  6 months

• Comparison of Alkaline Phosphatase Pre and Post Transplant

  The primary clinical study end point is the number of patients that achieve a 50% or more decrease serum alkaline phosphatase

  Baseline and 6 months

Secondary Outcomes (1)

• Microbiome

  6 months

Study Arms (1)

Patients with PSC

EXPERIMENTAL

This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Patients with PSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jessica Allegretti
• Organization: Brigham and Women's Hospital

jallegretti@bwh.harvard.edu

6177325500

Study Officials

• Joshua Korzenik, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Crohn's and Colitis Center

Study Record Dates

• First Submitted: April 18, 2015
• First Posted: April 22, 2015
• Study Start: February 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: May 8, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 21, 2019

Record last verified: 2018-08

Locations

US (1)