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NCT Number: NCT03479710

Fecal Microbiota Transplantation for CRE/VRE

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.

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Key information

Conditions

Antimicrobial Resistance Colonization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • Active infection with CRE or VRE requiring antimicrobial therapy
  • Pregnancy
  • Active gastrointestinal tract infection or inflammatory disorders
  • Recent intra-abdominal surgery
  • Short gut syndrome
  • Use of medications which alter gastrointestinal motility at the time of inclusion
  • 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

Treatment and study plan

FMT infusion

Biological

Fecal microbiota transplantation via OGD

Primary outcomes

  1. Intestinal colonization of CRE/VRE

    Time frame: 2 weeks to 12 months

    Absence of intestinal colonization of CRE/VRE

Secondary outcomes

  1. Adverse events

    Time frame: 12 months post FMT

    Incidence, severity and relatedness of adverse events

  2. Intestinal microbiota

    Time frame: Before and 12 months after FMT

    Changes in intestinal microbiota

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Fecal Microbiota Transplantation for Eradication of Intestinal Colonization of Carbapenem-resistant Enterobacteriaceae and Vancomycin-resistant Enterococcus: a Pilot Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2018
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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