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FMT for MDRO Colonization in Solid Organ Transplant (FMT)

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ClinicalTrials.gov Identifier: NCT02816437
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Lilian Abbo, University of Miami

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.

Condition or disease Intervention/treatment Phase
Infection Due to Resistant Organism Biological: OpenBiome Fecal Microbiota Transplantation retention enema Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients
Study Start Date : July 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: OpenBiome FMT retention enema
OpenBiome Fecal Microbiota Transplantation retention enema, one rectal application.
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"




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 10 months ]
    Overall rates of adverse events


Secondary Outcome Measures :
  1. Rate of MDRO decolonization [ Time Frame: 10 months ]
    Number of successful cases of MDRO decolonization

  2. Rate of Recurrent MDRO infections [ Time Frame: 10 months ]
    Number of patients with recurrent MDRO infections



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:   No
Criteria

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

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): NCT02816437


Contacts
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Contact: Olga Orozco, CCRC 305-585-8160 oorozco@med.miami.edu

Locations
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United States, Florida
Jackson Health System Recruiting
Miami, Florida, United States, 33136
Contact: Olga Orozco, CCRC    305-585-8160    oorozco@med.miami.edu   
Principal Investigator: Lilian Abbo, M.D.         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Lilian Abbo, M.D University of Miami

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Responsible Party: Lilian Abbo, Associate Profesor of Clinical Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02816437     History of Changes
Other Study ID Numbers: 20160351
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided