Probiotics and Hospital Outcome in the Elderly

Constipation Clinical Trial

— PROAGE  

Official title:

Effects of Commercially Available Probiotics on Hospital Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794924
• Other study ID #: Probiotics and elderly
• Status: Completed
• Phase: N/A
• First received: October 28, 2008
• Last updated: November 19, 2008
• Start date: February 2004
• Est. completion date: January 2005

Study information

• Verified date: November 2008
• Source: Kaplan-Harzfeld Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation
• Diarrhea

Intervention

Dietary Supplement:
• VSL#3
one sachet per day, for 45 consecutive days
• placebo
one sachet per day, for 45 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan-Harzfeld Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group		45 days of measuring the outcome	Yes
Secondary	Improvement in Nutritional and Immunological Measurements		45 days	Yes