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Fecal Microbiota Transplantation for CRE/VRE

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ClinicalTrials.gov Identifier: NCT03479710
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Grace Lui, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Antimicrobial Resistance Colonization Biological: FMT infusion Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for Eradication of Intestinal Colonization of Carbapenem-resistant Enterobacteriaceae and Vancomycin-resistant Enterococcus: a Pilot Study
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: 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.
Biological: FMT infusion
Fecal microbiota transplantation via OGD

No Intervention: Control
No FMT infusion.



Primary Outcome Measures :
  1. Intestinal colonization of CRE/VRE [ Time Frame: 2 weeks to 12 months ]
    Absence of intestinal colonization of CRE/VRE


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479710


Contacts
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Contact: Rity Wong +85235053376 ritywong@cuhk.edu.hk
Contact: Grace Lui +85235051464 gracelui@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Sha Tin, Hong Kong
Contact    35056000      
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Grace Lui CUHK

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Responsible Party: Grace Lui, Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03479710     History of Changes
Other Study ID Numbers: FMT protocol v.2 10Oct2017
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No