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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diarrhea
Constipation
Interventions Dietary Supplement: VSL#3
Dietary Supplement: placebo
Enrollment 345
Recruitment Details February 2004 to january 2005, all patients admitted to the Geriatric Rehabilitation Department of the Harzfeld Geriatric Mdical Center
Pre-assignment Details  
Arm/Group Title Probiotics Placebo
Hide Arm/Group 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.
Period Title: Overall Study
Started 174 [1] 171 [1]
Completed 114 101
Not Completed 60 70
Reason Not Completed
Lost to Follow-up             6             8
Withdrawal by Subject             48             60
Adverse Event             6             2
[1]
14 patients refused to start the study
Arm/Group Title Probiotics Placebo Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 174 171 345
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 171 participants 345 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
   2.9%
6
   3.5%
11
   3.2%
>=65 years
169
  97.1%
165
  96.5%
334
  96.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 174 participants 171 participants 345 participants
76.4  (8.5) 75.7  (8.6) 76.05  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 171 participants 345 participants
Female
90
  51.7%
80
  46.8%
170
  49.3%
Male
84
  48.3%
91
  53.2%
175
  50.7%
1.Primary Outcome
Title Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol.
Arm/Group Title Probiotics Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 114 101
Mean (Standard Deviation)
Unit of Measure: days of constipation or diarrhea
12  (2.4) 19  (3.9)
2.Secondary Outcome
Title Improvement in Nutritional and Immunological Measurements
Hide Description [Not Specified]
Time Frame 45 days
Outcome Measure Data Not Reported
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hilla Zaharoni
Organization: Kaplan-Harzfeld Geriatric Medical Center
Phone: 97288595350
EMail: hilla_z@clalit.org.il
Layout table for additonal information
Responsible Party: Hilla Zharoni, Chief dietician, Harzfeld Geriatric Medical Center
ClinicalTrials.gov Identifier: NCT00794924     History of Changes
Other Study ID Numbers: Probiotics and elderly
First Submitted: October 28, 2008
First Posted: November 20, 2008
Results First Submitted: October 28, 2008
Results First Posted: November 20, 2008
Last Update Posted: November 20, 2008