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Probiotics and Hospital Outcome in the Elderly

NCT ID: NCT00794924

Last Updated: 2008-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Diarrhea Constipation

Keywords

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probiotics elderly motility diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics, VSL#3

Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.

Group Type EXPERIMENTAL

VSL#3

Intervention Type DIETARY_SUPPLEMENT

one sachet per day, for 45 consecutive days

Placebo

Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.

Group Type PLACEBO_COMPARATOR

VSL#3

Intervention Type DIETARY_SUPPLEMENT

one sachet per day, for 45 consecutive days

placebo

Intervention Type DIETARY_SUPPLEMENT

one sachet per day, for 45 consecutive days

Interventions

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VSL#3

one sachet per day, for 45 consecutive days

Intervention Type DIETARY_SUPPLEMENT

placebo

one sachet per day, for 45 consecutive days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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probiotics VSL phrma,USA

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaplan-Harzfeld Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chief dietician, Harzfeld Geriatric Medical Center

Principal Investigators

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Hilla Zahroni, MA

Role: PRINCIPAL_INVESTIGATOR

Chief dietician

References

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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.

Reference Type DERIVED
PMID: 21369670 (View on PubMed)

Other Identifiers

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Probiotics and elderly

Identifier Type: -

Identifier Source: org_study_id