Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae

NCT05981430 | Unknown

• 1 other identifier: UW 19-512
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection; Fecal Microbiota Transplantation

Keywords

FMT; CRE

Outcome Measures

Primary Outcomes (1)

• CRE clearance rate

  CRE clearance rate via enema

  1 month post-FMT

Secondary Outcomes (2)

• CRE clearance rate

  1 week, 2 week, 3 month, 6 month and 12 month post-FMT

• All-cause mortality

  1 month, 3 month, 6 month and 12 month post-FMT

Study Arms (2)

Fecal microbiota transplant

ACTIVE COMPARATOR

This group's subject will receive an infusion of 125mL fecal suspension via enema.

Biological: Fecal microbiota transplant

Sham fecal microbiota transplant

PLACEBO COMPARATOR

This group's subject will receive 125mL placebo enema comprised of normal saline with 15% glycerol and brown food colouring 204 (Americolorcorp) as a sham procedure.

Biological: Sham fecal microbiota transplant

Interventions

Fecal microbiota transplant BIOLOGICAL

Active comparator will receive infusion of 125mL fecal suspension via enema

Fecal microbiota transplant

Sham fecal microbiota transplant BIOLOGICAL

Placebo comparator will receive 125mL placebo enema comprised of normal saline with 15% glycerol and brown food coloring 204 (Americolorcorp).

Sham fecal microbiota transplant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Hong Kong: lead

Related 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.

  PMID: 21429622 BACKGROUND

• 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.

  PMID: 28707337 BACKGROUND

• 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.

  PMID: 35461908 BACKGROUND

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ka Shing Cheung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Shing Cheung

CONTACT

22554769; cks634@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor. https://medic.hku.hk/en/Staff/University-Academic-Staff/Dr-CHEUNG-Ka-Shing-Michael/Dr-CHEUNG-Ka-Shing-Michael-Profile

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: January 1, 2024
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share