The aim of the study is evaluating the effect of probiotic in urinary tract infection. The inclusion criteria is the patients who admitted to intensive care unit and aged sixty and more, without any limitation for taking oral medicine. The exclusion criteria are the patients who have a history of chemotherapy, acute bowel obstruction, short bowel syndrome and acute pancreatitis. The study is a double blind randomized clinical trial. Fifty patients will enter to the study using random number table and will be allocated between two intervention and control groups. All patients will take two capsules daily for a week. The capsule used in intervention group contains lactocare. In control group, the capsules are as the same as intervention group, but without active material (placebo). For all patients, demographic data included age and gender will be collected. The urine analysis and the urine culture will be done for all patients in the admission day, and a week after the end of intervention (completion of taking the capsules). Finally, mortality rate will be measured one month later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111530906N1
Registration date:2017-02-21, 1395/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-21, 1395/12/03
Registrant information
Name
Sara Minaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2306
Email address
minaeian.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Iran University Medical of Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics in the prevention of urinary tract infections in elderly patients hospitalized in intensive care units
Public title
Studying the effect of probiotics in the prevention of urinary tract infection among elderlies
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The inclusion criteria included elder patients who aged sixty and more, and were admitted to the ICU, and did not have any limitation for taking medicine orally; Exclusion criteria: included the patients who had a history of chemotherapy previously and right now, acute bowel obstruction, short bowel syndrome and acute pancreatitis.
Age
From 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
53
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway,Tehran
City
Tehran
Postal code
Approval date
2015-05-18, 1394/02/28
Ethics committee reference number
IR.IUMS.REC.1394.92112497004
Health conditions studied
1
Description of health condition studied
Prevention of Urinary Tract Infections
ICD-10 code
N39-0
ICD-10 code description
Urinary tract infection, site not specified Use additional code (B95-B98), if desired, to identify infectious agent.
Primary outcomes
1
Description
Leukocyturia
Timepoint
Before intervention and a week after completion of taking the capsules
Method of measurement
Urinary analysis
2
Description
urinary tract infection
Timepoint
Before intervention and a week after completion of taking the capsules
Method of measurement
urinary culture
Secondary outcomes
1
Description
Mortality
Timepoint
On 30th day of intervention
Method of measurement
Followed up by phone call
Intervention groups
1
Description
Intervention group: Patients in this group received probiotic capsules containing 107 × 5 CFU viable lyophilized bacteria including 4 strains of Lactobacillus (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus Gasser and Lactobacillus Plantarm), twice a day for seven days.
Category
Prevention
2
Description
Control group: Patients in this group took the same shape capsules without active ingredient (placebo), twice a day for seven days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care unites 's Rasool Akram Hospital
Full name of responsible person
Mahshid Talabitaher
Street address
Rasool Akram Hospital, Mansouri street, Sattar Khan street