FMT for MDRO Colonization in Solid Organ Transplant

University of Miami

Status and phase

Withdrawn

Phase 1

Conditions

Infection Due to Resistant Organism

Treatments

Biological: OpenBiome Fecal Microbiota Transplantation retention enema

Study type

Interventional

Funder types

Other

Identifiers

NCT02816437

20160351

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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