Probiotics and Hospital Outcome in the Elderly (PROAGE)

November 19, 2008 updated by: Kaplan-Harzfeld Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

345

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics, VSL#3
Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
Dietary supplement: VSL#3
one sachet per day, for 45 consecutive days
Other Names:
  • probiotics
  • VSL phrma,USA
Placebo Comparator: Placebo
Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group
Time Frame: 45 days of measuring the outcome
Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.
45 days of measuring the outcome

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in Nutritional and Immunological Measurements
Time Frame: 45 days
45 days

Collaborators and Investigators

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

Sponsor

Kaplan-Harzfeld Medical Center

Investigators

  • Principal Investigator: Hilla Zahroni, MA, Chief dietician

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

February 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 20, 2008

Last Update Submitted That Met QC Criteria

November 19, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Probiotics and elderly

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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