Randomized Controlled Clinical Study of Treatment of Clostridioides Difficile Infection Comparing Fecal Microbiota Transplantation With Antibiotic Treatment

CDItransplant

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.

2024-05-01

2025-12-01

2026-01-01

Not yet recruiting

Early phase I

24

The inclusion criteria are: 1. Over 18 years old; 2. Hospitalized patients; 3. Clinical and laboratory diagnosis of CDI; 4. Signing the informed consent form 5. For primary CDI, use of antibiotics for less than 72 hours; and for recurrent CDI, previous confirmed CDI with clinical response to antibiotic treatment and CDI recurrence within 8 weeks. The exclusion criteria are: 1. Pregnant patients 2. Severe form of CDI requiring surgery 3. Impossibility of performing the colonoscopy procedure or using a nasoenteral tube

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-02-29