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 : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infection Due to Resistant Organism||Biological: OpenBiome Fecal Microbiota Transplantation retention enema||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2022|
|Estimated Study Completion Date :||December 2022|
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"
- Number of participants with adverse events [ Time Frame: 10 months ]Overall rates of adverse events
- 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
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
|Contact: Olga Orozco, CCRCfirstname.lastname@example.org|
|United States, Florida|
|Jackson Health System||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Olga Orozco, CCRC 305-585-8160 email@example.com|
|Principal Investigator: Lilian Abbo, M.D.|
|Principal Investigator:||Lilian Abbo, M.D||University of Miami|