Trial Outcomes & Findings for Probiotics and Hospital Outcome in the Elderly (NCT NCT00794924)

Results Overview

Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

345 participants

Primary outcome timeframe

45 days of measuring the outcome

Results posted on

2008-11-20

Participant Flow

February 2004 to january 2005, all patients admitted to the Geriatric Rehabilitation Department of the Harzfeld Geriatric Mdical Center

Participant milestones

Participant milestones
Measure	Probiotics Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.	Placebo Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
Overall Study STARTED	174	171
Overall Study COMPLETED	114	101
Overall Study NOT COMPLETED	60	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Probiotics Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.	Placebo Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
Overall Study Lost to Follow-up	6	8
Overall Study Withdrawal by Subject	48	60
Overall Study Adverse Event	6	2

Baseline Characteristics

Probiotics and Hospital Outcome in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Probiotics n=174 Participants Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.	Placebo n=171 Participants Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.	Total n=345 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	169 Participants n=5 Participants	165 Participants n=7 Participants	334 Participants n=5 Participants
Age Continuous	76.4 years STANDARD_DEVIATION 8.5 • n=5 Participants	75.7 years STANDARD_DEVIATION 8.6 • n=7 Participants	76.05 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	80 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	91 Participants n=7 Participants	175 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.

Outcome measures

Outcome measures
Measure	Probiotics n=114 Participants Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.	Placebo n=101 Participants Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
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	19 days of constipation or diarrhea Standard Deviation 3.9

SECONDARY outcome

Timeframe: 45 days

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hilla Zaharoni

Kaplan-Harzfeld Geriatric Medical Center

Phone: 97288595350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place