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Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424175
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : August 21, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Korzenik, Brigham and Women's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sclerosing Cholangitis
Intervention Biological: Fecal Microbiota Transplantation
Enrollment 10
Recruitment Details Recruitment for this study lasted from February 2016 until June 2017. 10 total patients were recruited through the Brigham and Women's Hospital Gastroenterology clinic and through referrals from other Gastroenterologists.
Pre-assignment Details A wash out period was included for patients. All subjects should not have used antibiotics within 2 months of start date or receive treatment of infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide within the past 8 weeks. They are also screened for various infectious risks such as HIV or Hepatitis.
Arm/Group Title Patients With PSC
Hide Arm/Group Description

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

Fecal Microbiota Transplantation

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Patients With PSC
Hide Arm/Group Description

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

Fecal Microbiota Transplantation

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
41.1
(23 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
Alkaline phosphatase  
Mean (Full Range)
Unit of measure:  U/L
Number Analyzed 10 participants
489
(111 to 1045)
Alanine Aminotransferase  
Mean (Full Range)
Unit of measure:  U/L
Number Analyzed 10 participants
150.7
(74 to 297)
Aspartate Aminotransferase  
Mean (Full Range)
Unit of measure:  U/L
Number Analyzed 10 participants
114.4
(60 to 270)
1.Primary Outcome
Title Adverse Event Frequency
Hide Description Number of patients with reporting adverse events irregardless of severity
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With PSC
Hide Arm/Group Description:

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

Fecal Microbiota Transplantation

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
2.Primary Outcome
Title Comparison of Alkaline Phosphatase Pre and Post Transplant
Hide Description The primary clinical study end point is the number of patients that achieve a 50% or more decrease serum alkaline phosphatase
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With PSC
Hide Arm/Group Description:

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

Fecal Microbiota Transplantation

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
3
  30.0%
3.Secondary Outcome
Title Microbiome
Hide Description Number of patients that experienced changes in the microbiome post FMT. Measured as similarity to the donor microbiome post FMT compared to their baseline sample
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With PSC
Hide Arm/Group Description:

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

Fecal Microbiota Transplantation

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
Time Frame Adverse event data was collected over 2 years from June 2016 through May 2018
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With PSC
Hide Arm/Group Description

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

Fecal Microbiota Transplantation

All-Cause Mortality
Patients With PSC
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Patients With PSC
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Infections and infestations   
Sinusitis  [1]  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
Patient had an infection that caused sinusitis and went to the ER to be treated.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With PSC
Affected / at Risk (%) # Events
Total   8/10 (80.00%)    
Gastrointestinal disorders   
Fever *  2/10 (20.00%)  3
diarrhea *  2/10 (20.00%)  2
Nausea/Vomiting *  1/10 (10.00%)  1
Abdominal Pain *  1/10 (10.00%)  1
General disorders   
Fatigue *  2/10 (20.00%)  2
Nervous system disorders   
MIgraine *  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Itchiness *  3/10 (30.00%)  3
Polyp *  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jessica Allegretti
Organization: Brigham and Women's Hospital
Phone: 6177325500
EMail: jallegretti@bwh.harvard.edu
Layout table for additonal information
Responsible Party: Joshua Korzenik, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02424175     History of Changes
Other Study ID Numbers: 2014P002475
First Submitted: April 18, 2015
First Posted: April 22, 2015
Results First Submitted: July 7, 2019
Results First Posted: August 21, 2019
Last Update Posted: August 28, 2019