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- Title
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.
- Authors
Yamada, Carolina Hikari; Ortis, Gabriel Burato; Buso, Gustavo Martini; Martins, Thalissa Colodiano; Zequinao, Tiago; Telles, Joao Paulo; Wollmann, Luciana Cristina; Montenegro, Carolina de Oliveira; Dantas, Leticia Ramos; Cruz, June Westarb; Tuon, Felipe Francisco
- Abstract
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–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–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.
- Subjects
FECAL microbiota transplantation; CLOSTRIDIOIDES difficile; HUMAN microbiota; GENOMICS; FECAL analysis
- Publication
Microorganisms, 2024, Vol 12, Issue 8, p1741
- ISSN
2076-2607
- Publication type
Article
- DOI
10.3390/microorganisms12081741