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FMT for MDRO Colonization in Solid Organ Transplant (FMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816437
Recruitment Status : Withdrawn (safety)
First Posted : June 28, 2016
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Lilian Abbo, University of Miami

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 28, 2016
Last Update Posted Date May 26, 2020
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
Number of participants with adverse events [ Time Frame: 10 months ]
Overall rates of adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
Number of participants with adverse events [ Time Frame: 10 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • Rate of MDRO decolonization [ Time Frame: 10 months ]
    Number of successful cases of MDRO decolonization
  • Rate of Recurrent MDRO infections [ Time Frame: 10 months ]
    Number of patients with recurrent MDRO infections
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • Rate of MDRO decolonization [ Time Frame: 10 months ]
    • Successful MDRO decolonization
  • Rate of Recurrent MDRO infections [ Time Frame: 10 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FMT for MDRO Colonization in Solid Organ Transplant
Official Title  ICMJE Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients
Brief Summary This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.
Detailed Description

This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.

Study participants who meet inclusion/exclusion criteria and provide written, informed consent will provide a pre-FMT stool sample. Participants will be followed from the time of enrollment up to 3 months post FMT.

Specific organisms of interest that will be tested for by the stool cultures include vancomycin resistant enterococcus, carbapenem resistant Enterobacteriaceae and carbapenem resistant Pseudomonas. Eligible patients who demonstrate colonization with a positive culture for a specific organism of interest will be given FMT.

One FMT dose of a retention rectal enema (OpenBiome) will be administered by a nurse and supervised by our principal investigator and/or sub-investigators trained in performance of FMT.

Stool samples of study participants will be collected and analyzed as follows:

  • Pre-FMT: Stool collection & storage in glycerol/flash frozen, to be shipped in dry ice
  • 48 hours post FMT: Stool collection using RNA later kit provided by OpenBiome (in hospital)
  • Day 7: Stool collection & storage in glycerol/flash frozen, to be shipped in dry ice
  • Day 14: Stool collection using RNAlater kit (at home)
  • Day 30: Stool collection & storage in glycerol/flash frozen (in hospital or clinic), to be shipped in dry ice
  • Day 90: follow-up visit in clinic, final sample collected using RNAlater kit
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infection Due to Resistant Organism
Intervention  ICMJE Biological: OpenBiome Fecal Microbiota Transplantation retention enema
Keep enema frozen until ready for administration. A single transfer of all 250mL of fecal material using universal precautions to a standard retention enema bag over 1 hour with material retained for at least 1 hour.
Other Name: Frozen Fecal Enema "OpenBiome"
Study Arms  ICMJE Experimental: OpenBiome FMT retention enema
OpenBiome Fecal Microbiota Transplantation retention enema, one rectal application.
Intervention: Biological: OpenBiome Fecal Microbiota Transplantation retention enema
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2016)
20
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age ≥18 years old
  • Solid organ transplant recipients: liver, intestinal, multivisceral transplants, heart, lung, pancreas or kidney transplant recipients
  • Transplant recipient at least >30 days post solid organ-transplant
  • Transplant recipient must be available locally for follow up to 6-months post FMT transplant
  • Inpatient status at time of FMT
  • History of at least one or more treated infections in the last 90 days (bacteremia, UTI, pneumonia or abdominal collection with a positive culture with MDRO) due to an MDRO and the MDRO is likely of enteric origin (carbapenem resistant enterobacteriaceae (CRE), vancomycin resistant enterococci (VRE) or carbapenem resistant Pseudomonas (CRP).
  • Be without active infection for >15 days: bacteremia, UTI, pneumonia or abdominal collection.
  • Be without a positive culture (except for stool) with MDRO (carbapenem resistant enterobacteriaceae (CRE), vancomycin resistant enterococci (VRE) or carbapenem resistant Pseudomonas (CRP)
  • Patients are not receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT
  • Solid organ prophylactic antimicrobials as per protocol will be held 24 hours before and 14 days post FMT e.g. trimethoprim/sulfamethoxazole 3x/week or dapsone 100 mg PO daily or weekly for PJP prophylaxis
  • Ganciclovir or valgancyclovir for CMV prophylaxis if required as per protocol can be continued.
  • Patients have a positive surveillance rectal culture for evidence of colonization.

Exclusion Criteria

  • Inability to provide informed consent
  • Physician-documented, severe allergy to nuts or other food allergens
  • Patients with allergies to ingredients Generally Recognized As Safe " glycerol, sodium chloride
  • Study participants hospitalized in the intensive care unit
  • CMV IgG, EBV IgG and PCR negative at the time of consent
  • Biological MELD score > 28 as defined by transplant surgeon
  • Pregnancy or inability/unwillingness to use contraceptives.
  • Autoimmune hepatitis
  • Patients that received a new solid organ transplant within the last 30 days at the time of enrollment
  • Patients on antibiotics treating an active infection or less than 2 weeks at the time of enrollment
  • Any circulatory failure on vasopressors
  • Respiratory failure (on mechanical ventilation) at the time of enrollment
  • Renal failure (GFR <30 or dialysis) at the time of enrollment
  • Any active Clostridium difficile infection regardless of severity
  • Post-allogeneic hematopoietic stem cell transplant recipients
  • ANC <1000/mm3
  • HIV+ controlled or not well controlled on antiretroviral therapy
  • At increased risk for peritonitis: presence of intra-abdominal devices, peritoneal dialysis.
  • Previous FMT
  • Patients undergoing treatment for liver or any other organ transplant rejection
  • Patients with graft vs. host disease
  • Patients with any active infection (bacteremia, pneumonia, urinary tract infection or abscess)
  • Life expectancy <1-year post transplant
  • Any clinical significant bleeding from a lower GI source (as defined as requiring blood transfusion, endoscopy or surgical or radiologic intervention) in the last 30 days.
  • Any condition that the physician investigators deems unsafe, feel the risks of outweigh potential benefit, including other conditions or medications that the investigator determines puts the subject at greater risk from FMT
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02816437
Other Study ID Numbers  ICMJE 20160351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lilian Abbo, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lilian Abbo, M.D University of Miami
PRS Account University of Miami
Verification Date May 2020

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