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Evaluation of the effect of probiotics on urinary tract infection in the elderly admitted in infection ward of Imam Hossain hospital of Shahroud a randomized clinical trial.

Protocol summary

Study aim
Determining the effect of probiotics on urinary tract infection in the elderly hospitalized in the infectious ward
Design
This double blind clinical trial is performed on 64 patients with urinary system infection that randomly divided into two equal groups In parallel. Block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose; 16 blocks with 4 subjects in each block will be used. For selecting each blocks; dice drooped and the block number will be selected. This procedure continued to completed the allocation and reached to sample size.
Settings and conduct
This study will be a clinical trial study with a control group that will be performed on 64 patients referred to the infectious ward of Imam Hossein hospital of Shahroud. Patients must sign an informed consent form before entering the study. In this study, patients were blinded to clinical care, outcome assessor and analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Minimum age of 60 years, urinary tract infection confirmed by E. coli and consent to participate in the study. Exclusion criteria: any autoimmune disease, unstable clinical condition, recent antibiotic use in last week, any agent Obstruction is in the path of the urinary tract system, kidney failure, diabetes, kidney transplant and the need for surgery.
Intervention groups
Patients included in the study were divided into intervention and control groups. In the intervention group, in addition to routine treatment, probiotic yoghurt will be treated for 14 days. In the control group, in addition to routine treatment, routine yoghurt treatment will be performed for 14 days.
Main outcome variables
Reduce the clinical symptoms of urinary tract infection including: fever, dysuria, recurrence, and urgency; Reducing the number of bacteria in urine analysis; Negative urine culture;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100102002954N18
Registration date: 2020-01-09, 1398/10/19
Registration timing: prospective

Last update: 2020-01-09, 1398/10/19
Update count: 0
Registration date
2020-01-09, 1398/10/19
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotics on urinary tract infection in the elderly admitted in infection ward of Imam Hossain hospital of Shahroud a randomized clinical trial.
Public title
Evaluation of the effect of probiotics on urinary tract infection in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with at least 60 years of age, Patients with a urinary tract infection proven by E. coli, Having the consent to participate in the project.
Exclusion criteria:
Any kind of autoimmune disease, Unstable clinical condition, Taking antibiotics in the last week, Kidney failure, Any obstructive factor in the path of the urinary tract system, Diabetes, The existence of a transplanted kidney, Need for surgery.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using permuted block randomization method using blocked random allocation syntax in SPSS software. For calculation sample size, number of blocks and block size was determined. Block size was 4. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients; clinical caregiver,outcome evaluator and analyzer it are blinded. The division of patients into two groups A and B is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Do clinical examination of patients and results recorder will be done by a qualified nurse without any knowledge of the type of intervention and patients group.
Placebo
Not used
Assignment
Parallel
Other design features
The patients enrolled in the study are divided into intervention and control groups. Patients in the intervention group will receive 250 ml of probiotic yoghurt twice daily (14 days) in addition to receiving routine treatment including appropriate serum and appropriate antibiotics. Patients in the control group will receive 250 ml of standard yoghurt twice daily (14 days) as the intervention group in addition to routine treatment including appropriate serum and antibiotics.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
IR.SHMU.REC.1397.082

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
Decrease in clinical symptoms of urinary tract infection including: fever, dysuria, recurrence and urgency.
Timepoint
Daily
Method of measurement
Patient examination and patient interview

2

Description
Reduce the number of bacteria in urine analysis
Timepoint
Two daily
Method of measurement
Standard urinalysis test

3

Description
Negative urine culture
Timepoint
Weekly
Method of measurement
Standard urine culture test

Secondary outcomes

1

Description
Recurrence of urinary tract infection
Timepoint
Monthly for three months
Method of measurement
Standard urine culture test

Intervention groups

1

Description
Intervention group: Patients in the intervention group will receive 250 ml of probiotic yoghurt twice daily for 14 days in addition to receiving routine therapy including appropriate serum and antibiotics.
Category
Treatment - Other

2

Description
Control group: Patients in the control group will receive 250 ml of standard yoghurt twice daily for 14 days in addition to receiving routine therapy including appropriate serum and antibiotics.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Ehsan Nezakati
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
drenezakati@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ghabel
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital., End Imam street.,
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
fate.qbl@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Ehsan Nezakati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Hossein Hospital., End Imam street.,
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
drenezakati@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital., End Imam street.,
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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