Treatment of Initial Clostridium Difficile Infection

Universidad Autonoma de Nuevo Leon

Status: Completed

Conditions: Clostridium Difficile Infection

Treatments: Other: FMT; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03107169

IF14-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of CDI (first episode)
• Older than 18 years old

Exclusion criteria

• Patients younger than 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Vancomycin

Active Comparator group

Description:

Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days

Treatment:

Drug: Vancomycin

FMT-FURM

Experimental group

Description:

Patients in this arm receive FMT-FURM

Treatment:

Other: FMT