Fecal Microbiota Transplantation for CRE/VRE

NCT03479710 | Completed Phase 2

• 1 other identifier: FMT protocol v.2 10Oct2017
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antimicrobial Resistance; Colonization

Outcome Measures

Primary Outcomes (1)

• Intestinal colonization of CRE/VRE

  Absence of intestinal colonization of CRE/VRE

  2 weeks to 12 months

Secondary Outcomes (2)

• Adverse events

  12 months post FMT

• Intestinal microbiota

  Before and 12 months after FMT

Study Arms (2)

FMT infusion

EXPERIMENTAL

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

Control

NO INTERVENTION

No FMT infusion.

Interventions

FMT infusion BIOLOGICAL

Fecal microbiota transplantation via OGD

FMT infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For cases:
• Age ≥18 years old
• Two or more stool or rectal swab positive for CRE or VRE at least one week apart.
• \[CRE is defined as presence of any Enterobacteriaceae with resistance to any of the carbapenems. VRE is defined as presence of Enterococcus species resistant to vancomycin.\]
• Not receiving antimicrobial therapy for at least 48 hours prior to infusion of FMT
• For controls:
• Age ≥18 years old
• Two or more stool or rectal swab positive for CRE or VRE at least one week apart.
• Not receiving antimicrobial therapy for at least 48 hours prior to infusion of FMT
• Refuse to consent for FMT infusion but consent for other study procedures listed in the protocol.

You may not qualify if:

• Active infection with CRE or VRE requiring antimicrobial therapy
• Pregnancy
• Active gastrointestinal tract infection or inflammatory disorders
• Recent intra-abdominal surgery
• Short gut syndrome
• Post-allogeneic hematopoietic stem cell transplant patients with history of gastrointestinal tract graft versus host disease
• Presence of intra-abdominal device which would increase risk of peritonitis
• ANC \<500/mm3
• HIV infection with CD4 \<200 cells/mm3
• On chemotherapy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Study Officials

• Grace Lui

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 27, 2018
• Study Start: February 10, 2018
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

HK (1)