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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

October 28, 2008
November 20, 2008
October 28, 2008
November 20, 2008
November 20, 2008
February 2004
January 2005   (Final data collection date for primary outcome measure)
Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group [ Time Frame: 45 days of measuring the outcome ]
Same as current
No Changes Posted
Improvement in Nutritional and Immunological Measurements [ Time Frame: 45 days ]
Same as current
Not Provided
Not Provided
 
Probiotics and Hospital Outcome in the Elderly
Effects of Commercially Available Probiotics on Hospital Outcome
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Diarrhea
  • Constipation
  • 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
  • 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
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.
 
Completed
345
Same as current
January 2005
January 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00794924
Probiotics and elderly
Yes
Not Provided
Not Provided
Hilla Zharoni, Chief dietician, Harzfeld Geriatric Medical Center
Kaplan-Harzfeld Medical Center
Not Provided
Principal Investigator: Hilla Zahroni, MA Chief dietician
Kaplan-Harzfeld Medical Center
November 2008

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