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OpenTrials
Completed

NCT Number: NCT00794924

Probiotics and Hospital Outcome in the Elderly

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSL#3

Dietary Supplement

one sachet per day, for 45 consecutive days

Other names: probiotics, VSL phrma,USA

Placebo

Dietary Supplement

one sachet per day, for 45 consecutive days

Primary outcomes

  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 outcomes

  1. Improvement in Nutritional and Immunological Measurements

    Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Kaplan-Harzfeld Medical Center

Other

Registry information

Official study title

Effects of Commercially Available Probiotics on Hospital Outcome

Acronym: PROAGE

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 20, 2008
Registry last updated
Nov 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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