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Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00722410
Recruitment Status : Unknown
Verified July 2008 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2008
Last Update Posted : July 25, 2008
Tel Aviv University
Information provided by:
Hadassah Medical Organization

Brief 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.

Condition or disease Intervention/treatment Phase
Anti-Biotic Resistance Klebsiella Pneumoniae Dietary Supplement: VSL#3 Drug: Polyethylene glycol Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
No Intervention: A
Experimental: B
VSL#3 for 4 weeks
Dietary Supplement: VSL#3
A probiotic preparation.

Experimental: C
Mechanical bowel cleansing followed by VSL#3 for 4 weeks.
Dietary Supplement: VSL#3
A probiotic preparation.

Drug: Polyethylene glycol
Oral ingestion of 3 liters of polyethylene glycol solution.
Other Names:
  • New Meroken.
  • Precolonoscopy solution.

Primary Outcome Measures :
  1. A negative stool culture for Carbapenem resistant Klebsiella pneumonia. [ Time Frame: 4 weeks. ]

Secondary Outcome Measures :
  1. A negative stool culture and/or PCR assay for CRKP at twelve weeks after initiation of probiotics (i.e - 8 weeks after cessation of probiotic treatment). [ Time Frame: 12 weeks beginning of intervention. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects who are > 18 years of age.
  2. Signing of informed consent by subject or legal custodian.
  3. Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
  4. Negative cultures for CRKP from extra-intestinal sites excluding urine.

Exclusion Criteria:

  1. Subjects who have participated in another clinical trial within the last three months.
  2. Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
  3. Subjects who are pregnant or breast feeding.
  4. Subjects who will be unavailable for the duration of the trial, are likely to be non-compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
  5. Subjects with chronic diarrhea (>4 weeks).
  6. Subjects with inflammatory bowel disease.
  7. Subjects whose stool is positive for Clostridium difficile toxin.
  8. Subjects receiving immunosuppressive treatment (i.e. corticosteroids; azathioprine or 6-MP; cyclosporine; tacrolimus; OKT3, methotrexate; anti TNF agents; chemotherapy).
  9. Subjects who underwent solid organ or hematopoietic stem cell transplantation.
  10. Subjects with primary or secondary immunodeficiency disorders, including HIV.
  11. Subjects with chronic advanced cardiac, respiratory, renal or liver disease.
  12. Subjects with advanced malignant disease.
  13. Subjects with severe acute organ failure.
  14. Subjects in whom CRKP is isolated from sites other than stool or urine (i.e. blood, sputum or wound cultures).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00722410

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Contact: Maya Margalit, MD 972-50-7874561
Contact: Hadas Lamberg, PhD 00 972 2 6777572

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Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lamberg, PhD    : 00 972 2 6777572   
Sub-Investigator: Reut Zaguri, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Tel Aviv University
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Principal Investigator: Maya Margalit, MD Hadassah Medical Organization

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Responsible Party: Maya Margalit, Hadassah Medical Organization Identifier: NCT00722410     History of Changes
Other Study ID Numbers: CRKP-HMO-CTIL
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: July 2008
Keywords provided by Hadassah Medical Organization:
Klebsiella pneumoniae
Additional relevant MeSH terms:
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Klebsiella Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections