FMT for MDRO Colonization in Solid Organ Transplant

NCT02816437 | Withdrawn Phase 1

• 1 other identifier: 20160351
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection Due to Resistant Organism

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Overall rates of adverse events

  10 months

Secondary Outcomes (2)

• Rate of MDRO decolonization

  10 months

• Rate of Recurrent MDRO infections

  10 months

Study Arms (1)

OpenBiome FMT retention enema

EXPERIMENTAL

OpenBiome Fecal Microbiota Transplantation retention enema, one rectal application.

Biological: OpenBiome Fecal Microbiota Transplantation retention enema

Interventions

OpenBiome Fecal Microbiota Transplantation retention enema BIOLOGICAL

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.

Also known as: Frozen Fecal Enema "OpenBiome"

OpenBiome FMT retention enema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Officials

• Lilian Abbo, M.D

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor of Clinical Medicine

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share