| 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
|
|
|
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. |