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Probiotics and Hospital Outcome in the Elderly (PROAGE)

Primary Purpose

Diarrhea, Constipation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VSL#3
placebo
Sponsored by
Kaplan-Harzfeld Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring probiotics, elderly, motility, diarrhea

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotics, VSL#3

    Placebo

    Arm Description

    Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.

    Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.

    Outcomes

    Primary Outcome Measures

    Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group
    Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.

    Secondary Outcome Measures

    Improvement in Nutritional and Immunological Measurements

    Full Information

    First Posted
    October 28, 2008
    Last Updated
    November 19, 2008
    Sponsor
    Kaplan-Harzfeld Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00794924
    Brief Title
    Probiotics and Hospital Outcome in the Elderly
    Acronym
    PROAGE
    Official Title
    Effects of Commercially Available Probiotics on Hospital Outcome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    January 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kaplan-Harzfeld Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diarrhea, Constipation
    Keywords
    probiotics, elderly, motility, diarrhea

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    345 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics, VSL#3
    Arm Type
    Experimental
    Arm Description
    Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    VSL#3
    Other Intervention Name(s)
    probiotics, VSL phrma,USA
    Intervention Description
    one sachet per day, for 45 consecutive days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    one sachet per day, for 45 consecutive days
    Primary Outcome Measure Information:
    Title
    Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group
    Description
    Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.
    Time Frame
    45 days of measuring the outcome
    Secondary Outcome Measure Information:
    Title
    Improvement in Nutritional and Immunological Measurements
    Time Frame
    45 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hilla Zahroni, MA
    Organizational Affiliation
    Chief dietician
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21369670
    Citation
    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. doi: 10.1007/s12603-010-0323-3.
    Results Reference
    derived

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    Probiotics and Hospital Outcome in the Elderly

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