Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

INTRODUCTION 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. Currently, pseudomembranous colitis has few treatment options: the main one is fidaxomicin, unavailable in Brazil, and other alternatives are vancomycin and metronidazole. However, refractoriness to alternative treatments may occur, with fecal transplantation also being an alternative. Additionally, fecal transplantation is often associated with better outcomes than drug alternatives, reaching more than 90% clinical success. Fecal microbiota transplantation (FMT) can occur through different routes, for example, via nasoenteral tube, colonoscopy, oral capsules or enemas, with colonoscopy or capsules normally being apparently more effective than enemas and nasoenteral tubes. Furthermore, the preparation of stool samples can be either fresh or frozen, which do not influence the effectiveness of the treatment. Since 2020, the PUCPR Fecal Microbiota Bank has been carrying out validation studies of a product, PROMICROBIOMA, composed of freeze-dried human fecal microbiota, which has already tested its safety in a phase 1 study on consecutive patients in a convenience sample. To evaluate the effectiveness of the product, it is important to carry out a controlled and randomized clinical study comparing it with antimicrobial therapy. HYPOTHESIS H0 - PROMICROBIOMA is equal to antibiotic treatment in primary or recurrent CDI H1 - PROMICROBIOME is superior to antibiotic treatment in primary or recurrent CDI H2 - PROMICROBIOME is inferior to antibiotic treatment in primary or recurrent CDI MAIN GOAL To evaluate the clinical outcome of patients with primary or recurrent CDI using PROMICROBIOMA compared to antimicrobial therapy. METHODS Study design This is a randomized, controlled clinical study of patients with primary or recurrent CDI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06107569
Study type Interventional
Source Hospital Universitario Evangelico de Curitiba
Contact
Status Not yet recruiting
Phase Phase 3
Start date May 1, 2024
Completion date January 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT06030245 - Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance
Completed NCT01957761 - Molecular Epidemiology of Clostridium Difficile Infections in Children N/A
Recruiting NCT05714566 - Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients
Recruiting NCT06237452 - VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 3
Not yet recruiting NCT06398379 - Virus as Treatment of C. Difficile Infection (VISION) N/A
Not yet recruiting NCT05256693 - Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant Phase 3
Recruiting NCT06311006 - Safety Registry of a Fecal Microbiota Transplant Cohort
Recruiting NCT05430269 - Faecal Bacteriotherapy for Postantibiotic Diarrhoea in Critically Ill Patients N/A