Constipation, Diarrhea
Conditions
Keywords
probiotics, elderly, motility, diarrhea
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTVSL#3
one sachet per day, for 45 consecutive days
DIETARY_SUPPLEMENTplacebo
one sachet per day, for 45 consecutive days
Sponsors
Kaplan-Harzfeld Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group | 45 days of measuring the outcome | Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea. |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Nutritional and Immunological Measurements | 45 days |
Participant flow
Recruitment details
February 2004 to january 2005, all patients admitted to the Geriatric Rehabilitation Department of the Harzfeld Geriatric Mdical Center
Participants by arm
| Arm | Count |
|---|---|
| Probiotics Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. | 174 |
| Placebo Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days. | 171 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 2 |
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Withdrawal by Subject | 48 | 60 |
Baseline characteristics
| Characteristic | Probiotics | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 169 Participants | 165 Participants | 334 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Age Continuous | 76.4 years STANDARD_DEVIATION 8.5 | 75.7 years STANDARD_DEVIATION 8.6 | 76.05 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 90 Participants | 80 Participants | 170 Participants |
| Sex: Female, Male Male | 84 Participants | 91 Participants | 175 Participants |
Outcome results
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.
Time frame: 45 days of measuring the outcome
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotics | Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group | 12 days of constipation or diarrhea | Standard Deviation 2.4 |
| Placebo | Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group | 19 days of constipation or diarrhea | Standard Deviation 3.9 |
Secondary
Improvement in Nutritional and Immunological Measurements
Time frame: 45 days