Validation of Lyophilized Human Fecal Microbiota for the Treatment of Clostridioides difficile Infection: A Pilot Study with Pharmacoeconomic Analysis of a Middle-Income Country—Promicrobioma Project
2024
Carolina Hikari Yamada | Gabriel Burato Ortis | Gustavo Martini Buso | Thalissa Colodiano Martins | Tiago Zequinao | Joao Paulo Telles | Luciana Cristina Wollmann | Carolina de Oliveira Montenegro | Leticia Ramos Dantas | June Westarb Cruz | Felipe Francisco Tuon
Background: Clostridioides difficile infection (CDI) represents a prevalent and potentially severe health concern linked to the usage of broad-spectrum antibiotics. The aim of this study was to evaluate a new lyophilized product based on human fecal microbiota for transplant, including cost&ndash:benefit analysis in the treatment of recurrent or refractory CDI. Methods: The product for fecal microbiota transplant was obtained from two donors. Microbiological, viability, and genomic analysis were evaluated. After validation, a clinical pilot study including recurrent or refractory CDI with 24 patients was performed. Clinical response and 4-week recurrence were the outcome. Cost&ndash:benefit analysis compared the fecal microbiota transplant with conventional retreatment with vancomycin or metronidazole. Results: The microbiota for transplant presented significant bacterial viability, with and adequate balance of Firmicutes and Bacteroidetes. The clinical response with the microbiota transplant was 92%. In financial terms, estimated expenditure for CDI solely related to recurrence, based on stochastic modeling, totals USD 222.8 million per year in Brazil. Conclusions: The lyophilized human fecal microbiota for transplant is safe and can be an important step for a new product with low cost, even with genomic sequencing. Fecal microbiota transplantation emerges as a more cost-effective alternative compared to antimicrobials in the retreatment of CDI.
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