NCT00722410

Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will decrease the rate of GI colonization by CRKP.

Detailed description

CRKP colonization will be determined by culture and PCR of rectal swabs. The study will include 3 arms - no intervention, probiotics and mechanical bowel cleansing + probiotics. Followup examination of rectal swab samples for the presence of CRKP will be performed at 4 weeks and 12 weeks from study entry.

Conditions

• Anti-Biotic Resistance
• Klebsiella Pneumoniae

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VSL#3	A probiotic preparation.
DRUG	Polyethylene glycol	Oral ingestion of 3 liters of polyethylene glycol solution.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-07-25
• Last updated: 2008-07-25

Locations

1 site across 1 country: Israel