NCT03107169

Treatment of Initial Clostridium Difficile Infection

Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Universidad Autonoma de Nuevo Leon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.

Detailed description

Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR). The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method. Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
OTHER	FMT	Patients in the FMT group received FMT-FURM
DRUG	Vancomycin	Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-09-30
• Completion: 2015-09-30
• First posted: 2017-04-11
• Last updated: 2017-04-18