The purpose of this study is to better understand the efficacy and safety of microbiome therapies (MT) in patients with Multidrug Resistant Organism (MDRO) colonization who are admitted to Long Term Acute Care Hospitals (LTACH). This use of MT has been studied in other small studies to treat MDRO colonization, further study of the effect of MT on the transmission of MDRO to other patients is needed. This study will test the safety of the MT for this use in LTACH patients, and how well it works to help design larger studies. Importance to the field: MDRO colonization increases the risk of subsequent infection and transmission to others, however, there are no approved therapies for decolonization or reduction of the burden of colonization with MDROs. MT like Allogeneic Microbiota in Glycerol (AMG) has been shown to have \~ 60-90% efficacy for decolonization and an acceptable safety profile but has not been studied in this population for this indication. Study population: patients admitted to long-term care facilities (e.g. LTACHs and ventilator-capable skilled nursing facilities \[vSNF\]) found to be MDRO colonized during prevalence screening activities. The MT AMG will be delivered through an already existing feeding tube or into the rectum as an enema.
Age range
18 Years
Sex
ALL
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Frequency of adverse events by MT administration in a population with a high burden of comorbidities
Timeframe: Day 7
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
Timeframe: Day 7
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
Timeframe: Day 0 up to 196 days
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
Timeframe: Day 0 up to 196 days