Study of probiotic complementary effects in combination with Antibiotic in treatment of Recurrent urinary tract infection in Female patients: A Randomized Clinical Trial
The study aims to evaluate the effects of probiotic complementary in combination with Antibiotic in treatment of Recurrent urinary tract infection.
The main inclusion criteria include: age 18-80 years old; Female patients; Definitive diagnosis of Recurrent urinary tract infection confirmed by a specialist.
Exclusion criteria include: presence of anatomic disorder, history of predisposing disease like diabetes mellitus.
Plan: this is a randomized clinical trial, 162 patients with Recurrent urinary tract infection referring to urology clinic of Baghiatallah Hospital in Tehran will enter the study.
Interventions:After the random selection of patients, Familact Capsule and Routine Antibiotic will be prescribed orally to the intervention group and the control group will receive only routine antibiotics, for 1 month.
Primary outcome is presence of urinary tract infection defined by urine analysis and urine culture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090323871N1
Registration date:2016-02-06, 1394/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Seyyed Ebrahim Moussavi Mirak
Name of organization / entity
Baghiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3692
Email address
se.moussavi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of probiotic complementary effects in combination with Antibiotic in treatment of Recurrent urinary tract infection in Female patients: A Randomized Clinical Trial
Public title
Study of probiotic complementary effects in combination with Antibiotic in treatment of Recurrent urinary tract infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age 18-80 years old; Female patients; Definitive diagnosis of Recurrent urinary tract infection confirmed by a specialist.
Exclusion Criteria: presence of anatomic disorder, history of predisposing disease like diabetes mellitus.
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baghiatallah University of Medical Sciences
Street address
Baghiatallah University of Medical Sciences, Molasadra Street, Vanak Square, Tehran
City
Tehran
Postal code
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
ir.bmsu.REC.1394.108
Health conditions studied
1
Description of health condition studied
Urinary Tract Infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Presence of Urinary tract infection
Timepoint
1, 3 and 6 month after intervention
Method of measurement
Evaluation of Lower urinary tract symptoms by history taking, physical examination, Urinalysis and Urine Culture
Secondary outcomes
1
Description
recurrence rate of Urinary tract infection
Timepoint
1, 3 and 6 month after intervention
Method of measurement
Urinalysis and Urine Culture
Intervention groups
1
Description
control group: oral prescription of Antibiotics based on Urine Culture, daily, for 1 month.
Category
Treatment - Drugs
2
Description
Intervention group: oral prescription of Antibiotics based on Urine Culture and a Familact capsule, daily, for 1 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology clinic of Baghiatallah Hospital in Tehran
Full name of responsible person
Seyyed Ebrahim Moussavi Mirak
Street address
Baqiyatallah Hospital, Molasadra Street, Vanak Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Shahin Abbaszadeh
Street address
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Molasadra Street, Vanak Square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology and Urology Research Center, Baqiyatallah 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
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Fatemeh Heidari
Position
Endourologic Laparoscopic Fellowship, Faculty Member
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Molasadra Street, Vanak Square, Tehran
City
Tehran
Postal code
Phone
+98 21 8126 2073
Fax
Email
fhei50@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Seyyed Ebrahim Moussavi
Position
Resident of Urology
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Molasadra Street, Vanak Square, Tehran
City
Tehran
Postal code
Phone
+98 21 8126 2073
Fax
Email
se.moussavi@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baghiatallah University of Medical Sciences
Full name of responsible person
Seyyed Ebrahim Moussavi Mirak
Position
Resident of Urology
Other areas of specialty/work
Street address
Baghiatallah University of Medical Sciences, Molasadra Street, Vanak Square, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
se.moussavi@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)