Fecal Microbiota Transplantation for CRE/VRE

NCT ID: NCT03479710

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-10
• Study Completion Date: 2022-07-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FMT infusion

Intervention Type: BIOLOGICAL

Fecal microbiota transplantation via OGD

Control

No FMT infusion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FMT infusion

Fecal microbiota transplantation via OGD

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

For cases:

1. Age ≥18 years old

2. 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.]

3. Not receiving antimicrobial therapy for at least 48 hours prior to infusion of FMT

For controls:

1. Age ≥18 years old

2. Two or more stool or rectal swab positive for CRE or VRE at least one week apart.

3. Not receiving antimicrobial therapy for at least 48 hours prior to infusion of FMT

4. Refuse to consent for FMT infusion but consent for other study procedures listed in the protocol.

Exclusion Criteria

1. Active infection with CRE or VRE requiring antimicrobial therapy

2. Pregnancy

3. Active gastrointestinal tract infection or inflammatory disorders

4. Recent intra-abdominal surgery

5. Short gut syndrome

6. Use of medications which alter gastrointestinal motility at the time of inclusion

7. Post-allogeneic hematopoietic stem cell transplant patients with history of gastrointestinal tract graft versus host disease

8. Presence of intra-abdominal device which would increase risk of peritonitis

9. ANC <500/mm3

10. HIV infection with CD4 <200 cells/mm3

11. On chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Grace Lui

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Lui

Role: PRINCIPAL_INVESTIGATOR

CUHK

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

FMT protocol v.2 10Oct2017

Identifier Type: -

Identifier Source: org_study_id