Probiotics and Hospital Outcome in the Elderly (PROAGE)

• 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: Kaplan-Harzfeld Medical Center
• Information provided by: Kaplan-Harzfeld Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Diarrhea; Constipation	Dietary Supplement: VSL#3; Dietary Supplement: placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 345 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Commercially Available Probiotics on Hospital Outcome
• Study Start Date: February 2004
• Actual Primary Completion Date: January 2005
• Actual Study Completion Date: January 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Improvement in Nutritional and Immunological Measurements [ Time Frame: 45 days ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Kaplan-Harzfeld Medical Center

Investigators

• Principal Investigator: Hilla Zahroni, MA; Chief dietician

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hilla Zharoni, Chief dietician, Harzfeld Geriatric Medical Center
• ClinicalTrials.gov Identifier: NCT00794924
• Other Study ID Numbers: Probiotics and elderly
• First Posted: November 20, 2008
• Results First Posted: November 20, 2008
• Last Update Posted: November 20, 2008
• Last Verified: November 2008

Keywords provided by Kaplan-Harzfeld Medical Center:

probiotics; elderly; motility; diarrhea

Additional relevant MeSH terms:

Constipation; Diarrhea; Signs and Symptoms, Digestive