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Probiotics and Hospital Outcome in the Elderly (PROAGE)

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ClinicalTrials.gov Identifier: NCT00794924
Recruitment Status : Completed
First Posted : November 20, 2008
Results First Posted : November 20, 2008
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:
Kaplan-Harzfeld Medical Center

Tracking Information
First Submitted Date  ICMJE October 28, 2008
First Posted Date  ICMJE November 20, 2008
Results First Submitted Date  ICMJE October 28, 2008
Results First Posted Date  ICMJE November 20, 2008
Last Update Posted Date November 20, 2008
Study Start Date  ICMJE February 2004
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group [ Time Frame: 45 days of measuring the outcome ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Improvement in Nutritional and Immunological Measurements [ Time Frame: 45 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics and Hospital Outcome in the Elderly
Official Title  ICMJE Effects of Commercially Available Probiotics on Hospital Outcome
Brief Summary Probiotics have been shown to reduce the rate of diarrhea and constipation. The purpose of this study was to investigate if probiotics could improve outcome of hospitalized orthopedic elderly patients.
Detailed Description The patients were divided into two groups. One received probiotics for 45 days and the second received placebo. The patients had a clinical and epidemiological as well as nutritional assessment. They were followed-up as for their bowel movements, abdominal pain and nosocomial infections and for the incidence of helicobacter pylori and clostridiume difficille diarrhea.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diarrhea
  • Constipation
Intervention  ICMJE
  • Dietary Supplement: VSL#3
    one sachet per day, for 45 consecutive days
    Other Names:
    • probiotics
    • VSL phrma,USA
  • Dietary Supplement: placebo
    one sachet per day, for 45 consecutive days
Study Arms  ICMJE
  • Experimental: Probiotics, VSL#3
    Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
    Intervention: Dietary Supplement: VSL#3
  • Placebo Comparator: Placebo
    Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
    Interventions:
    • Dietary Supplement: VSL#3
    • Dietary Supplement: placebo
Publications * Zaharoni H, Rimon E, Vardi H, Friger M, Bolotin A, Shahar DR. Probiotics improve bowel movements in hospitalized elderly patients--the PROAGE study. J Nutr Health Aging. 2011 Mar;15(3):215-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2008)
345
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who were hospitalized in the Department of Geriatric Orthopedic Rehabilitation a week before their enrollment in the study and signed an informed consent.

Exclusion Criteria:

  • Known or suspected allergy to any probiotics
  • Neutropenia
  • Inability to sign an informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794924
Other Study ID Numbers  ICMJE Probiotics and elderly
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hilla Zharoni, Chief dietician, Harzfeld Geriatric Medical Center
Study Sponsor  ICMJE Kaplan-Harzfeld Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hilla Zahroni, MA Chief dietician
PRS Account Kaplan-Harzfeld Medical Center
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP