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CTRI Number  CTRI/2020/05/025175 [Registered on: 14/05/2020] Trial Registered Prospectively
Last Modified On: 13/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Studying the role of probiotic in the treatment of urinary tract infections in women 
Scientific Title of Study   Studying the role of probiotic in the treatment of recurrent uncomplicated urinary tract infections in women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abu Syed Md Mosaddek 
Designation  Principal Investigator 
Affiliation  Uttara Adhunik Medical College 
Address  Department of Pharmacology Uttara Adhunik Medical College Sonargaon Janapath Uttara Dhaka Bangladesh



1230
Other 
Phone  1711483814  
Fax    
Email  Drmosaddek1968@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abu Syed Md Mosaddek 
Designation  Principal Investigator 
Affiliation  Uttara Adhunik Medical College 
Address  Department of Pharmacology Uttara Adhunik Medical College Sonargaon Janapath Uttara Dhaka Bangladesh



1230
Other 
Phone  1711483814  
Fax    
Email  Drmosaddek1968@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abu Syed Md Mosaddek 
Designation  Principal Investigator 
Affiliation  Uttara Adhunik Medical College 
Address  Department of Pharmacology Uttara Adhunik Medical College Sonargaon Janapath Uttara Dhaka Bangladesh



1230
Other 
Phone  1711483814  
Fax    
Email  Drmosaddek1968@gmail.com  
 
Source of Monetary or Material Support  
Bangladesh Medical Research Council 
 
Primary Sponsor  
Name  Bangladesh Medical Research Council 
Address  BMRC Bhaban, MOHAKHALI, DHAKA-1212, BANGLADESH  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Purnava Ltd  Plot 1, Milkvita road, Dhaka-1216, Bangladesh 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Abu Syed Md Mosaddek  Department of Gynaecology and Department of Pharmacology, Uttara Adhunik Medical College.  1. Department Gynaecology, 2nd floor, House: 34, Road: 04, Sector: 09, Uttara-1230, Dhaka, Bangladesh 2. Department of Pharmacology, 13th floor, House: 34, Road: 04, Sector: 09, Uttara-1230, Dhaka, Bangladesh

 
1711483814

Drmosaddek1968@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Review Committee, Uttara Adhunik Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antibiotics  Patients will be treated with antibiotics according to hospital treatment guideline regarding urinary tract infection for at least 7 days.Antibiotics may be changed according to sensitivity report of organism responsible for UTI.  
Intervention  Lactobacillus acidophilus (2 billion), Lactobacillus bulgaricus (1 billion), Bifidobactaterium bifidum (1 billion), and Fructooligosaccharides (100 mg)  Each capsule contains: Lactobacillus acidophilus (2 billion), Lactobacillus bulgaricus (1 billion), Bifidobactaterium bifidum (1 billion), and Fructooligosaccharides (100 mg). The dose and regimen of probiotic will be two capsules each containing Lactobacillus acidophilus (2 billion), Lactobacillus bulgaricus (1 billion), Bifidobactaterium bifidum (1 billion), and Fructooligosaccharides (100 mg) three times daily orally until recovery or for 14 days.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  i. Sex: female
ii.Female suffering from only recurrent uncomplicated UTI
iii. Patients have not received any antimicrobial and/or probiotic therapy within one month prior to enrollment in the study.
iv. Non-pregnant women
 
 
ExclusionCriteria 
Details  i. Sex: Male
ii. Status: Pregnant women
ii. Patients received any antimicrobial and/or probiotic therapy within one month prior to enrollment in the study.
iii. Patients having relevant interactions of prescribed antimicrobial agent or probiotics with concurrent medication or contraindications.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. The number of patients is cured of UTI due to administration of probiotics/antibiotics. It will be based on absence or decreased severity of clinical signs-symptoms after completion of course of probiotics and antibiotics.

2.Identification of the organisms responsible for UTI and evaluation of the development of antibiotic resistance by expressing in percentage of antibiotic resistant E. Coli isolate from urine of symptomatic women.  
At Baseline, 2 weeks and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. The micro biologically confirmed recovery of patients suffering from UTI.


2. Proportion of patients’ experienced adverse events. 
At baseline, 2 weeks and 4 weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/05/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Urinary Tract Infections (UTIs) currently rank amongst the most prevalent infections representing a major health hazard. Urogenital infections are one of most common causes for a woman to visit a gynecologist or a urologist. UTIs in female usually start as vaginal infections and ascend to the urethra and bladder. Various antibiotics have been the mainstay of therapy in ameliorating the incidence of UTIs, but recurrent infections continue to afflict many women. In recent years due to irrational use of antibiotics for the treatment of bacterial infections like UTIs, antibiotic resistance has been reached at an alarming level. Use of broad-spectrum antibiotics not only kills the pathogenic bacteria but also beneficial bacteria hosted by the human body. It necessitates the exploitation of alternative  to antimicrobial therapy. Probiotics may be one of highly effective alternative treatment option. Healthy vaginal microbiota is mainly dominated by Lactobacillus species but in UTIs its level in vaginal flora decreases. Escherichia coli is the main pathogen that causes UTIs. Restoration of normal urogenital flora by exogenously administered probiotics containing Lactobacilli play a pivotal role in reducing the risk and treatment of uncomplicated, complicated, recurrent UTIs or patients on prolonged antibiotic use. Probiotics do not cause antibiotic resistance and may offer other health benefits due to vaginal re-colonization with Lactobacilli. This study will be conducted to assess the clinical efficacy of probiotic therapy and compare the effect of  probiotic and antibiotic therapy on urogenital microbiota. In this study total 90 women suffering from only recurrent uncomplicated UTIs will be enrolled and divided into three groups. Preliminary, conventionally microbiological culture method will be used for the detection of vaginal flora. The study will use urine only. Personal information will be kept confidential. 

Verbal or properly signed written consent will be obtained before collecting any specimen and demographic data. Hopefully the result of this study will help to reduce the inappropriate use of antibiotics and also reduce potentially "illness promoting" dysbiosis  in women suffering from UTIs. It will also open a new alternative treatment therapy. In our understanding, there is no research data available to date in Bangladesh. Our study will contribute in developing baseline data in Bangladesh to study further in this critical area. 
 
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