Probiotics and Hospital Outcome in the Elderly (PROAGE)

This study has been completed.
Sponsor:
Information provided by:
Kaplan-Harzfeld Medical Center
ClinicalTrials.gov Identifier:
NCT00794924
First received: October 28, 2008
Last updated: November 19, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention
Diarrhea
Constipation
Dietary Supplement: VSL#3
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Commercially Available Probiotics on Hospital Outcome

Resource links provided by NLM:


Further study details as provided by Kaplan-Harzfeld Medical Center:

Primary Outcome Measures:
  • Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group [ Time Frame: 45 days of measuring the outcome ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in Nutritional and Immunological Measurements [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]

Enrollment: 345
Study Start Date: February 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794924

Sponsors and Collaborators
Kaplan-Harzfeld Medical Center
Investigators
Principal Investigator: Hilla Zahroni, MA Chief dietician
  More Information

No publications provided by Kaplan-Harzfeld Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hilla Zharoni, Chief dietician, Harzfeld Geriatric Medical Center
ClinicalTrials.gov Identifier: NCT00794924     History of Changes
Other Study ID Numbers: Probiotics and elderly
Study First Received: October 28, 2008
Results First Received: October 28, 2008
Last Updated: November 19, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Kaplan-Harzfeld Medical Center:
probiotics
elderly
motility
diarrhea

Additional relevant MeSH terms:
Constipation
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014