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Trial record 28 of 90 for:    Recruiting Studies | fecal microbiota transplantation

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

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date April 12, 2019
Actual Study Start Date  ICMJE February 10, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2018)
Intestinal colonization of CRE/VRE [ Time Frame: 2 weeks to 12 months ]
Absence of intestinal colonization of CRE/VRE
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03479710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2018)
  • Adverse events [ Time Frame: 12 months post FMT ]
    Incidence, severity and relatedness of adverse events
  • Intestinal microbiota [ Time Frame: Before and 12 months after FMT ]
    Changes in intestinal microbiota
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for CRE/VRE
Official Title  ICMJE Fecal Microbiota Transplantation for Eradication of Intestinal Colonization of Carbapenem-resistant Enterobacteriaceae and Vancomycin-resistant Enterococcus: a Pilot Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Antimicrobial Resistance
  • Colonization
Intervention  ICMJE Biological: FMT infusion
Fecal microbiota transplantation via OGD
Study Arms  ICMJE
  • 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.
    Intervention: Biological: FMT infusion
  • No Intervention: Control
    No FMT infusion.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rity Wong +85235053376 ritywong@cuhk.edu.hk
Contact: Grace Lui +85235051464 gracelui@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03479710
Other Study ID Numbers  ICMJE FMT protocol v.2 10Oct2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Grace Lui, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grace Lui CUHK
PRS Account Chinese University of Hong Kong
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP