Efficacy of the Probiotic Yogurt in Prevention of Urinary Tract Infection among People with Stroke, Hospitalized in the Hospital Affiliated with North Khorasan University of Medical Sciences in 2011-2012
The aim of this study is to evaluate the effect of Probiotic yogurt to preventing of urinary tract infection. Inclusion criteria were: negative urine culture; starting on oral diet; food tolerance; use of urinary catheter; receiving no prior antibiotic treatment and willingness to participate in the research. Exclusion criteria: immunosuppressant; taking corticosteroids; inability to eat food and starting antibiotic treatment during the research. A randomized controlled clinical trial was conducted in 60 hospitalized patients with stroke who should have undergone urinary catheterization. Data was collected by data collection form. Urine sampling was done for all patients. Those with negative culture were randomly assigned The intervention group received 200 gram daily probiotic yogurt 1/5% fat containing yogurt starter bacteria plus Lactobacillus acidophilus LA-5 & Bifido bacterium BB-12 and Control group 200 gram daily of normal yogurt 1/5% fat containing normal yogurt starter bacteria (Streptococcus thermophilus, Lactobacillus bulgaricus ) for a period 3 days. After this period, urine samples were collected again and the results of the two groups were compared. In this study the main outcome variables is urinary tract infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042813154N1
Registration date:2013-07-20, 1392/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Batoul Mahmoudi
Name of organization / entity
North Khorasan University of Medical of Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 58 5622 4011
Email address
bt438@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the Probiotic Yogurt in Prevention of Urinary Tract Infection among People with Stroke, Hospitalized in the Hospital Affiliated with North Khorasan University of Medical Sciences in 2011-2012
Public title
The Effect of Probiotic Yogurt in Prevention of Urinary Tract Infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: negative urine cultivation; starting to eat and bear food; use of urinary catheter; undergoing no antibiotic treatment and willingness to participate in the research.
Exclusion criteria: immunosuppression; taking corticosteroids; inability to eat food and starting antibiotic treatment during the research.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the University of Medical Sciences
Street address
Tehran University of Medical Sciences, Khaghani St, Shariati St
City
Tehran
Postal code
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
1008
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
B95,B96,B9
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Prevention of urinary tract infection
Timepoint
The first day & fourth day
Method of measurement
Urine culture
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received 200 gr daily probiotic yogurt 1/5% fat containing yogurt starter bacteria plus Lactobacillus acidofillus LA-5 & Bifidobacterium BB-12 for a period of 3 days.
Category
Prevention
2
Description
Control group received 200 gr daily of normal yogurt 1/5% fat containing normal yogurt starter bacteria (Streptococcus thermophilus, Lactobacillus bulgaricus ) for a period 3 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Shirvan
Full name of responsible person
Batoul Mahmoudi
Street address
Imam Khomeini Hospital, Imam Reza St, Shirvan, North khorasan, Iran
City
Shirvan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, North Khorasan University of Medical Sciences
Full name of responsible person
Alireza Golshan
Street address
Government boulevard, Bojnurd, North khorasan
City
Bojnurd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, North Khorasan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
North Khorasan University of medical Sciences
Full name of responsible person
Batoul Mahmoudi
Position
Ms in Nursing Students
Other areas of specialty/work
Street address
Imam khomeini Hospital, Imam Reza St, Shirvan, North Khorasan
City
Shirvan
Postal code
Phone
+98 58 5622 4011
Fax
Email
bt438@nkums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Batoul Mahmoudi
Position
Ms in Nursing Students
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Imam Reza st, Shirvan, North Khorasan
City
Shirvan
Postal code
Phone
+98 58 5622 4011
Fax
Email
bt438@nkums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Batoul Mahmoudi
Position
Ms in Nursing Students
Other areas of specialty/work
Street address
North Khorasan
City
Shirvan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)