Probiotics and Hospital Outcome in the Elderly (PROAGE)
This study has been completed.
Sponsor:
Kaplan-Harzfeld Medical Center
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
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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:
|
|
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:
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 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, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013