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Sponsors and Collaborators: |
Hadassah Medical Organization Tel Aviv University |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00722410 |
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.
Condition | Intervention | Phase |
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Anti-Biotic Resistance Klebsiella Pneumoniae |
Dietary Supplement: VSL#3 Drug: Polyethylene glycol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics. |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: No Intervention | |
B: Experimental
VSL#3 for 4 weeks
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Dietary Supplement: VSL#3
A probiotic preparation.
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C: Experimental
Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
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Dietary Supplement: VSL#3
A probiotic preparation.
Drug: Polyethylene glycol
Oral ingestion of 3 liters of polyethylene glycol solution.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maya Margalit, MD | 972-50-7874561 | mayam@hadassah.org.il |
Contact: Hadas Lamberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Maya Margalit, MD | Hadassah Medical Organization |
Responsible Party: | Hadassah Medical Organization ( Maya Margalit ) |
Study ID Numbers: | CRKP-HMO-CTIL |
Study First Received: | July 23, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00722410 History of Changes |
Health Authority: | Israel: Ministry of Health |
Carbapenem resistant Klebsiella pneumoniae |
Carpapenemases Probiotics VSL3 |
Bacterial Infections Klebsiella Respiratory Tract Infections Respiratory Tract Diseases Enterobacteriaceae Infections |
Lung Diseases Klebsiella Infections Pneumonia Gram-Negative Bacterial Infections |
Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Enterobacteriaceae Infections |
Lung Diseases Klebsiella Infections Pneumonia Gram-Negative Bacterial Infections |