drugset / Trial / NCT06107569

Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

NCT06107569

Phase 3 Unknown 24 enrolled Hospital Universitario Evangelico de Curitiba
RandomizedParallel-groupOpen-labelTreatment

Summary

The increasing inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). The intestinal microbiota is mainly composed of the phyla Firmicutes, Bacteroidetes, Acinobacteria, Proteobacteria, Fusobacteria and Verrucomicrobia, and more than 90% of the phylum Firmicutes is composed of Clostridium spp. (two). The inappropriate use of antimicrobials initiates a process of dysregulation of the microbiome, called dysbiosis, and it is from the selection of genera and species of bacteria that will dominate the intestine that pseudomembranous colitis can set in with an increased burden of Clostridioides difficile, a gram positive, anaerobic, spore-forming, that produces two enterotoxins, toxin A and toxin.

Timeline

Start
2024-05-01
Primary completion
2025-12-01
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metronidazole Small molecule Intravenous
Comparator Vancomycin Other / unclassified Oral