Fecal Microbiota Transplantation for CRE/VRE
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|ClinicalTrials.gov Identifier: NCT03479710|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 12, 2019
Multidrug-resistant organisms (MDRO) present an increasingly serious public health threat to the global community.The prevalence of various MDRO, including carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococcus (VRE), has been increasing worldwide, and some have become endemic in certain countries. Data from the Hospital Authority showed that the number of carbapenemase- producing Enterobacteriaceae (CPE) cases increased from 36 in 2012 to 134 in 2015. A large outbreak of VRE involving >200 patients was recently reported in a tertiary hospital in Hong Kong.
The primary site of colonization and persistence of most MDRO is in the gastrointestinal tract. Carriage can persist for months, with up to 40% of individuals still having colonization one year after hospital discharge. Outbreaks of MDRO have been reported in hospitals and long-term care facilities. Around 10% of patients colonized with MDRO would develop clinical infections by the same organism. Infections caused by these MDRO carry significant morbidity and high mortality of up to 50%, however, there is no proven therapy for eradication of intestinal colonization of MDRO.
There is accumulating evidence showing that the gut microbiota plays an important role in the control of intestinal colonization and infection by pathogenic bacteria. Administration of obligate anaerobic commensal bacteria to mice has been shown to markedly reduce VRE colonization. Preliminary evidence, mainly from anecdotal reports, have shown that fecal microbiota transplantation (FMT) in human carriers of MDRO were safe and potentially effective in eliminating intestinal colonization by various MDRO, including CRE and VRE, even in immunocompromised patients. Therefore, investigators hypothesize that FMT will be safe and potentially effective in eradicating intestinal colonization of CRE and VRE.
This is a prospective pilot study to evaluate whether FMT is safe and effective to eradicate intestinal colonization of CRE and VRE.
|Condition or disease||Intervention/treatment||Phase|
|Antimicrobial Resistance Colonization||Biological: FMT infusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation for Eradication of Intestinal Colonization of Carbapenem-resistant Enterobacteriaceae and Vancomycin-resistant Enterococcus: a Pilot Study|
|Actual Study Start Date :||February 10, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: FMT infusion
FMT will be performed using frozen donor stool samples obtained from the stool bank of CUHK. 100-200ml of FMT solution or sterile saline will be infused over 2-3 minutes into the distal duodenum or jejunum via OGD.
Biological: FMT infusion
Fecal microbiota transplantation via OGD
No Intervention: Control
No FMT infusion.
- Intestinal colonization of CRE/VRE [ Time Frame: 2 weeks to 12 months ]Absence of intestinal colonization of CRE/VRE
- Adverse events [ Time Frame: 12 months post FMT ]Incidence, severity and relatedness of adverse events
- Intestinal microbiota [ Time Frame: Before and 12 months after FMT ]Changes in intestinal microbiota
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): NCT03479710
|Contact: Rity Wongemail@example.com|
|Contact: Grace Luifirstname.lastname@example.org|
|Prince of Wales Hospital||Recruiting|
|Sha Tin, Hong Kong|
|Principal Investigator:||Grace Lui||CUHK|