Fecal Microbiota Transplantation Clinical Trial
Official title:
Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae: a Double Blind Randomized Controlled Trial
The emergence of multidrug-resistant organisms (MDROs) has become one of the major threats to the healthcare system in Hong Kong in recent years. The situation is particularly worrisome for carbapenem-resistant Enterobacteriaceae (CRE). Taking Queen Mary Hospital as an example, the number of CRE cases has surged from 24 in year 2014 to 625 in year 2021. The case burden in Hong Kong is therefore substantial when all 43 public hospitals and institutions in Hong Kong are considered. With the widespread use of broad-spectrum antibiotics and active case screening, the number of CRE cases is expected to further increase in an exponential manner. Given that colonization with MDROs is due to gut dysbiosis from antibiotic use, a normal intestinal microbiota is apparently crucial in protecting hosts from colonization with MDROs including CRE. Fecal microbiota transplantation (FMT), which involves the infusion of stool from a healthy donor to the gastrointestinal (GI) tract of a recipient, has gained popularity in recent years to restore colonic microbial diversity in various diseases associated with gut dysbiosis, e.g. Clostridium difficile (CD) infection, ulcerative colitis and even metabolic diseases. The investigators aim to conduct a double-blind randomized controlled trial to evaluate the benefit of FMT via lower GI delivery (enema) on CRE clearance.
CRE colonization is associated with a 16.5% risk of infection with a 10% mortality rate. CRE also poses a tremendous strain on the healthcare cost as well as the medical/nursing manpower. The hospital stay is lengthened by two-fold for CRE-infected cases compared with non-infected cases. CRE carriers frequently have to stay in acute hospitals for extended periods of time after settling their acute illnesses, both because of the logistic infeasibility of them being transferred to rehabilitation units or nursing homes, which are devoid of isolation rooms. Proactive measures have been implemented in hospitals worldwide to prevent the spread of MDROs, especially to vulnerable individuals. Such measures usually include surveillance culture, contact tracing, isolation of carriers and environmental disinfection. Nevertheless, isolation facilities are not always readily available, particularly in resource-limited regions. In addition, contact isolation may result in various adverse effects on the mental well-being of isolated patients, such as depression, anxiety and anger. Time spent with patients in isolation by healthcare workers is less, with a negative effect on patient safety with an eight-fold increase in the risk of adverse events due to supportive care failure. There has been a growing interest in extending FMT for the decolonization of CRE. However, most of the studies are limited to case reports or case series with small sample sizes (ranging from 10 to 39 patients) as shown by a recent systematic review. The pooled rate of CRE decolonization is promising at 62.1%. However, a randomized controlled trial (RCT) remains the most optimal study design to investigate the true beneficial effect of FMT on CRE decolonization. FMT via enema route has several advantages over upper GI delivery or colonoscopy. First, the administration of fecal suspension via a feeding tube may not be acceptable to some patients. Second, colonoscopy carries complications of gut perforation, aspiration, and cardiopulmonary suppression from the use of sedatives, in particular among frail and elder patients. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04436874 -
Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease
|
N/A | |
Recruiting |
NCT03325855 -
Fecal Microbiota Transplant National Registry
|
||
Completed |
NCT06162702 -
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
|
N/A | |
Active, not recruiting |
NCT05607745 -
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
|
N/A | |
Completed |
NCT05121285 -
Distribution of FMT After Delivery by · Lower GI Endoscopy vs Enema With and Without Positioning of the Patient
|
N/A | |
Active, not recruiting |
NCT05917379 -
The Safety and Efficacy of FMT in Patients With CID
|
Phase 1/Phase 2 | |
Recruiting |
NCT02318147 -
Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)
|
Phase 1 | |
Completed |
NCT02318134 -
Fecal Microbiota Transplantation for Pancreatitis
|
Phase 2 | |
Completed |
NCT05035784 -
RCE With FMT in the Treatment of Childhood Constipation
|
N/A | |
Active, not recruiting |
NCT04173208 -
Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
|
N/A | |
Terminated |
NCT04577729 -
The IRMI-FMT Trial
|
N/A | |
Not yet recruiting |
NCT02435160 -
The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04837313 -
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
|
N/A | |
Recruiting |
NCT04861649 -
Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition
|
N/A | |
Withdrawn |
NCT04078581 -
Profiling Fecal Samples for Selection of Donors of Feces
|
N/A | |
Recruiting |
NCT05821010 -
Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT05273255 -
Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy
|
N/A | |
Not yet recruiting |
NCT05253222 -
Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET
|
N/A | |
Recruiting |
NCT04285424 -
FMT for Steroid Resistant Gut Acute GVHD
|
Early Phase 1 | |
Withdrawn |
NCT03527056 -
Pilot Study Using Oral Capsule FMT to Decolonize GI CRE
|
Early Phase 1 |