Treatment of Initial Clostridium Difficile Infection

Clostridium Difficile Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107169
• Other study ID #: IF14-005
• Status: Completed
• Phase: N/A
• First received: March 21, 2017
• Last updated: April 15, 2017
• Start date: February 1, 2015
• Est. completion date: September 30, 2015

Study information

• Verified date: April 2017
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of CDI (first episode)

• Older than 18 years old

Exclusion Criteria:

• Patients younger than 18 years old

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Communicable Diseases
• Infection

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in number of evacuations	The cure of CDI was measured	up to a 2 days