MedTrace Logo

Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

NCT06107569 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-29

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Infections

Interventions

OTHER

Fecal microbiota transplant (Promicrobioma)

Fecal microbiota transplant with Promicrobioma (freeze-dried isolated microbiota)

DRUG

Antibiotic

Antibiotics for Clostridioides infection (oral vancomycin) or association of intravenous metronidazol for severe cases.

Sponsors & Collaborators

  • Hospital Universitario Evangelico de Curitiba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107569 on ClinicalTrials.gov