Treatment of Initial Clostridium Difficile Infection

Not Applicable

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Vancomycin; Other: FMT

• Registration Number: NCT03107169
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

Brief 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.

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2015-09-30
• Study Completion: 2015-09-30
• Study First Submitted: 2017-03-21
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Last Update Submitted: 2017-04-15
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• Patients younger than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days
FMT-FURM	FMT	Patients in this arm receive FMT-FURM

Primary Outcome Measures

Name	Time	Method
Decrease in number of evacuations	up to a 2 days	The cure of CDI was measured