Comparison of the incidence of bloating and indigestion in the two groups
Design
This study is a parallel double-blind clinical trial in which patients will be randomly divided into case (probiotic) and control (placebo) groups.
Settings and conduct
The study population is patients referred to the clinics of Golestan and Imam Khomeini hospitals in 1399.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All premenopausal women referring to UTI over the age of 18 who are willing to participate in the study will be included in the study.
The following patients are excluded from the study:
1- Patients who have needed long-term prophylactic antibiotics due to recurrent urinary tract infections in the last 6 months.
2- Patients who have a urinary catheter
Intervention groups
Probiotic intervention will be prescribed for the intervention group and placebo for the control group
Main outcome variables
UTI recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048943N1
Registration date:2020-12-11, 1399/09/21
Registration timing:registered_while_recruiting
Last update:2020-12-11, 1399/09/21
Update count:0
Registration date
2020-12-11, 1399/09/21
Registrant information
Name
Narjes Yazdi baghban zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4224 5671
Email address
ybznarges@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the probiotic,s(lactofem) efficacy and complication on acute non complicated cystitis infection among women of reproductive age
Public title
Probiotics (lactofem) in the prevention of recurrence of infection in acute uncomplicated cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All premenopausal women with UTI
Satisfaction to participate in the study
Exclusion criteria:
Patients who have needed long-term prophylactic antibiotics due to recurrent urinary tract infections in the last 6 months.
Patients who have a urinary catheter
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into case and control groups.
Random function of Excel software based on patient file number will be used for randomization. Patients with uncomplicated acute cystitis were included in the Excel program based on the file number and were divided into case and control groups based on the random button. A total of two groups of 24 people were divided. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want to have 24 people in each group. As a result, sequences 1 to 2 should be repeated 24 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 24 for repeating the sequence. In this way, 48 units will be produced. Which patient is included in which group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the clinical caregiver knows which patients are in the case group and should be prescribed probiotics, and for which group placebo is required.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.AJUMS.REC.1399.189
Health conditions studied
1
Description of health condition studied
Acute uncomplicated cystitis
ICD-10 code
N30.0
ICD-10 code description
Acute cystitis
Primary outcomes
1
Description
Reduce relapse
Timepoint
At the beginning of the study and at the end of each month, patients will be visited during the study period.
Method of measurement
Ask the patient about changes in the patient as well as urinary symptoms and gastrointestinal complications
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The probiotic lactofem made by the bio-fermentation company starts at the rate of one per day.The drug is administered in the afternoon and 5 hours after lunch with a glass of cold water.
Category
Treatment - Drugs
2
Description
Control group: A placebo that is similar in appearance (color-shape) to the original drug is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Shokouh Shayanpour
Street address
Farvardin Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3374 3001
Fax
Email
info@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Shokouh Shayanpour
Street address
Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3311 0000
Fax
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
does not have
Proportion provided by this source
1
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
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3311 0000
Email
dr.shayanpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Narges Yazdi Baghbanzadeh
Position
Student of Medical Science
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3311 0000
Fax
Email
Narges.ybz@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available