Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05981430
Other study ID # UW 19-512
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date August 19, 2025

Study information

Verified date December 2023
Source The University of Hong Kong
Contact Ka Shing Cheung
Phone 22554769
Email cks634@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date August 19, 2025
Est. primary completion date August 19, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - All adult patients aged 18 or above admitted to the medical ward of Queen Mary Hospital, the teaching hospital of the University of Hong Kong - Rectal swabs or stool specimens showing the presence of CRE - Positive CRE specimen within one week of commencement Exclusion Criteria: - Pregnancy - Severe immunodeficiency (e.g. advanced human immunodeficiency virus infection (CD4 lymphocyte count =200/mm3), myelosuppressive chemotherapy) - Significant neutropenia (absolute neutrophil count =1.0 x 109/L) - Recent antibiotic use within 30 days prior to consent - Contraindications for retention enema (intestinal obstruction, ileus and gut perforation).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Fecal microbiota transplant
Active comparator will receive infusion of 125mL fecal suspension via enema
Sham fecal microbiota transplant
Placebo comparator will receive 125mL placebo enema comprised of normal saline with 15% glycerol and brown food coloring 204 (Americolorcorp).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

References & Publications (3)

Backman C, Taylor G, Sales A, Marck PB. An integrative review of infection prevention and control programs for multidrug-resistant organisms in acute care hospitals: a socio-ecological perspective. Am J Infect Control. 2011 Jun;39(5):368-378. doi: 10.1016/j.ajic.2010.07.017. Epub 2011 Mar 23. — View Citation

Macareno-Castro J, Solano-Salazar A, Dong LT, Mohiuddin M, Espinoza JL. Fecal microbiota transplantation for Carbapenem-Resistant Enterobacteriaceae: A systematic review. J Infect. 2022 Jun;84(6):749-759. doi: 10.1016/j.jinf.2022.04.028. Epub 2022 Apr 21. — View Citation

Quraishi MN, Widlak M, Bhala N, Moore D, Price M, Sharma N, Iqbal TH. Systematic review with meta-analysis: the efficacy of faecal microbiota transplantation for the treatment of recurrent and refractory Clostridium difficile infection. Aliment Pharmacol Ther. 2017 Sep;46(5):479-493. doi: 10.1111/apt.14201. Epub 2017 Jul 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CRE clearance rate CRE clearance rate via enema 1 month post-FMT
Secondary CRE clearance rate CRE clearance rate post-FMT 1 week, 2 week, 3 month, 6 month and 12 month post-FMT
Secondary All-cause mortality All-cause mortality post-FMT 1 month, 3 month, 6 month and 12 month post-FMT
See also
  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