Trial Outcomes & Findings for Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis. (NCT NCT02424175)

NCT ID: NCT02424175

Last Updated: 2019-08-28

Results Overview

Number of patients with reporting adverse events irregardless of severity

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-08-28

Participant Flow

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.

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.

Participant milestones

Measure	Patients With PSC This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

Baseline characteristics by cohort

Measure	Patients With PSC n=10 Participants This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Age, Continuous	41.1 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Alkaline phosphatase	489 U/L n=5 Participants
Alanine Aminotransferase	150.7 U/L n=5 Participants
Aspartate Aminotransferase	114.4 U/L n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Number of patients with reporting adverse events irregardless of severity

Outcome measures

Measure	Patients With PSC n=10 Participants This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Adverse Event Frequency	8 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

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

Outcome measures

Measure	Patients With PSC n=10 Participants This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Comparison of Alkaline Phosphatase Pre and Post Transplant	3 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Patients With PSC n=10 Participants This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Microbiome	8 Participants

Adverse Events

Patients With PSC

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients With PSC n=10 participants at risk This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Infections and infestations Sinusitis	10.0% 1/10 • Number of events 1 • Adverse event data was collected over 2 years from June 2016 through May 2018

Other adverse events

Measure	Patients With PSC n=10 participants at risk This is an open label study. All patients enrolled will receive a fecal microbiota transplantation. Fecal Microbiota Transplantation
Gastrointestinal disorders Fever	20.0% 2/10 • Number of events 3 • Adverse event data was collected over 2 years from June 2016 through May 2018
Gastrointestinal disorders diarrhea	20.0% 2/10 • Number of events 2 • Adverse event data was collected over 2 years from June 2016 through May 2018
General disorders Fatigue	20.0% 2/10 • Number of events 2 • Adverse event data was collected over 2 years from June 2016 through May 2018
Skin and subcutaneous tissue disorders Itchiness	30.0% 3/10 • Number of events 3 • Adverse event data was collected over 2 years from June 2016 through May 2018
Nervous system disorders MIgraine	10.0% 1/10 • Number of events 1 • Adverse event data was collected over 2 years from June 2016 through May 2018
Gastrointestinal disorders Nausea/Vomiting	10.0% 1/10 • Number of events 1 • Adverse event data was collected over 2 years from June 2016 through May 2018
Skin and subcutaneous tissue disorders Polyp	10.0% 1/10 • Number of events 1 • Adverse event data was collected over 2 years from June 2016 through May 2018
Gastrointestinal disorders Abdominal Pain	10.0% 1/10 • Number of events 1 • Adverse event data was collected over 2 years from June 2016 through May 2018

Additional Information

Dr. Jessica Allegretti

Brigham and Women's Hospital

Phone: 6177325500

Email: jallegretti@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place