Treatment of Initial Clostridium Difficile Infection

NCT ID: NCT03107169

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2015-09-30

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.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vancomycin

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

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)

FMT-FURM

Patients in this arm receive FMT-FURM

Group Type: EXPERIMENTAL

FMT

Intervention Type: OTHER

Patients in the FMT group received FMT-FURM

Interventions

FMT

Patients in the FMT group received FMT-FURM

Intervention Type: OTHER

Vancomycin

Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)

Intervention Type: DRUG

Other Intervention Names

fecal microbiota transplant; Glycopeptide

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients younger than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role: lead

Responsible Party

Adrián Camacho-Ortiz

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IF14-005

Identifier Type: -

Identifier Source: org_study_id