Fecal Microbiota Transplantation for Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT01742754|
Recruitment Status : Terminated (IND required by the FDA for all future FMTs.)
First Posted : December 5, 2012
Last Update Posted : November 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Fecal Microbiota Transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon.
Other: Fecal Microbiota Transplantation
Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.
- Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation. [ Time Frame: 4 weeks ]Metagenomic shotgun sequencing using Iluminia technology will be used to evaluate for engraftment. Metagenomic data will be analyzed using CompareReads. A % similarity to the recipient > than % similarity to the donor will be defined as engraftment.
- Engraftment of fecal microbiota transplantation at 7 days. [ Time Frame: 7 days ]As in primary aim but at 7 days.
- Durability of Fecal Microbiota Transplantation at 12 weeks [ Time Frame: 12 weeks ]As in primary aim but at 12 weeks.
- Clinical remission at 4 weeks. [ Time Frame: 4 weeks ]Defined as Mayo score <=2 with no subscore >1
- Clinical remission at 12 weeks. [ Time Frame: 12 weeks ]Defined as Mayo score <=2 with no subscore >1
- Endoscopic remission at 4 weeks. [ Time Frame: 4 weeks ]Mayo endoscopy scope of 0.
- Number of patients with worsened disease. [ Time Frame: 4 weeks. ]Increase in Mayo score of >2.
- Number of adverse events. [ Time Frame: 12 weeks. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742754
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98103|
|Principal Investigator:||Timothy L Zisman, MD||University of Washington|