Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
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|ClinicalTrials.gov Identifier: NCT02424175|
Recruitment Status : Active, not recruiting
First Posted : April 22, 2015
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sclerosing Cholangitis||Biological: Fecal Microbiota Transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Patients with PSC
This is an open label study. All patients enrolled will receive a fecal microbiota transplantation.
|Biological: Fecal Microbiota Transplantation|
- Comparison of microbiome pre and post transplant [ Time Frame: 12 weeks ]The investigators will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. The investigators will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
- Comparison of liver biochemistries pre and post transplant [ Time Frame: 12 weeks ]The primary study end point is them mean change serum liver biochemistries after 3 months of treatment as compared with baseline. Treatment success was defined as an improvement in serum alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) by 50 % or greater.
- Adverse event frequency [ Time Frame: 6 months ]Number of patients with reporting adverse events with type and severity of adverse events reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424175
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Joshua Korzenik, MD||Brigham and Women's Hospital|