Probiotics and Hospital Outcome in the Elderly

Not Applicable

Completed

• Conditions: Diarrhea; Constipation
• Interventions: Dietary Supplement: VSL#3; Dietary Supplement: placebo

• Registration Number: NCT00794924
• Lead Sponsor: Kaplan-Harzfeld Medical Center

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-10-28
• Results First Submitted: 2008-10-28
• Status Verified: 2008-11
• Study First Submitted QC: 2008-11-19
• Results First Submitted QC: 2008-11-19
• Last Update Submitted: 2008-11-19
• Study First Posted: 2008-11-20
• Results First Posted: 2008-11-20
• Last Update Posted: 2008-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	VSL#3	Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
Probiotics, VSL#3	VSL#3	Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
Placebo	placebo	Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.

Primary Outcome Measures

Name	Time	Method
Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group	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

Name	Time	Method
Improvement in Nutritional and Immunological Measurements	45 days