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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics, VSL#3 | Experimental | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. |
|
| Placebo | Placebo Comparator | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Dietary Supplement | one sachet per day, for 45 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group | Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea. | 45 days of measuring the outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Nutritional and Immunological Measurements | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilla Zahroni, MA | Chief dietician | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21369670 | Derived | 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. |
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February 2004 to january 2005, all patients admitted to the Geriatric Rehabilitation Department of the Harzfeld Geriatric Mdical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Probiotics | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. |
| FG001 | Placebo | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Probiotics | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group | Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea. | The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol. | Posted | Mean | Standard Deviation | days of constipation or diarrhea | 45 days of measuring the outcome |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilla Zaharoni | Kaplan-Harzfeld Geriatric Medical Center | 97288595350 | hilla_z@clalit.org.il |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| placebo | Dietary Supplement | one sachet per day, for 45 consecutive days |
|
| Adverse Event |
|
Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
|
|
| Secondary | Improvement in Nutritional and Immunological Measurements | Not Posted | 45 days |
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| D019602 |
| Food and Beverages |