Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

July 24, 2008 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
        • Contact:
        • Sub-Investigator:
          • Reut Zaguri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A negative stool culture for Carbapenem resistant Klebsiella pneumonia.
Time Frame: 4 weeks.
4 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
12 weeks beginning of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: Maya Margalit, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRKP-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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