Fecal Microbiota Transplantation for Ulcerative Colitis
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|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. ]
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): NCT01742754
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98103|
|Principal Investigator:||Timothy L Zisman, MD||University of Washington|