| CTRI Number |
CTRI/2024/11/077444 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Do oral Lactobacillus tablets help in prevention of recurrent UTI in females |
|
Scientific Title of Study
|
Does oral Lactobacillus therapy help in prevention of recurrent UTI as compared to oral antibiotic prophylaxis- A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Ram |
| Designation |
Assistant professor |
| Affiliation |
AIIMS |
| Address |
Room no 243, urology OPD, 2nd floor, AIIMS Campus, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9686559576 |
| Fax |
|
| Email |
dr.praspr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Ram |
| Designation |
Assistant professor |
| Affiliation |
AIIMS |
| Address |
room no 243, urology opd, 2nd floor., AIIMS Campus, Bhubaneswar
ORISSA
751019
India |
| Phone |
9686559576 |
| Fax |
|
| Email |
dr.praspr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Ram |
| Designation |
Assistant professor |
| Affiliation |
AIIMS |
| Address |
Room no 243, urology opd, 2nd floor, AIIMS Campus, Bhubaneswar
ORISSA
751019
India |
| Phone |
9686559576 |
| Fax |
|
| Email |
dr.praspr@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS campus, sijua, patrapada, Bhubaneswar, odisha 751019 |
|
|
Primary Sponsor
|
| Name |
Aiims Bhubanesswar |
| Address |
Sijua, Patrapada, Bhubaneswar, Odisha 751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swarnendu Mandal |
AIIMS, Bhubaneswar |
Room no 243, 2nd floor, Urology OPD, Patrapada, Bhubaneswar, 751019
Khordha
ORISSA |
09686559576
ram_pras@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS BHUBANESWAR |
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 |
Oral Antibiotics |
Patients shall be given oral culture-specific antibiotic therapy according to the current guidelines, followed by prophylactic oral antibiotic therapy for 3 months. |
| Intervention |
Oral Lactobacillus |
Patients shall be given oral lactobacillus therapy in the form of tablets thrice daily for 1 week followed once daily for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged 18 years or above with culture-proven recurrent UTIs
Written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Complicated cystitis
2.Uncomplicated pyelonephritis
3.A history of urologic abnormality or renal calculi
4.Recent sexually transmitted infections (STI)
5.History of recurrent Bacterial vaginosis
6.Risk factors for STI and human immunodeficiency virus (HIV) infection
7.Pregnancy or within 2 months of pregnancy
8.Lactation
9.Uncontrolled Diabetes (controlled would be enrolled)
10.Other immunocompromised states
11.Drug or alcohol abuse
Abnormal pelvic examination results |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the rate of symptomatic UTIs (clinical recurrences (CR)) during the 3 months of therapy, as reported by the patient |
at presentation
at 1 month
at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a)To measure the number of microbiologically confirmed symptomatic UTIs (microbiologic recurrences) during the 3 months of prophylaxis. |
at presentation
at 1 month
at 3 months |
| b)To compare the time to the first Microbiologic Recurrence (MR). An MR was defined as a UTI based on the combination of clinical symptoms and bacteriuria (103 CFU/mL bacteria in midstream urine). |
at presentation
at 1 month
at 3 months |
| c)The most common causative microorganism in Indian women. |
at presentation
at 1 month
at 3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
30/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recurrent UTIs are emerging as a serious health concern in women. They are a common cause of morbidity in sexually active women, both pre and post-menopausal. It is known that depletion of vaginal lactobacilli is associated with UTI risk, hence, repletion may be beneficial. Recurrent UTI is defined as the occurrence of at least 3 episodes of UTI in the last 12 months or 2 episodes in the last 6 months. Studies show that one third of all women will have at least one episode of uncomplicated UTI by the age of 26 and amongst these around 25%-30% will have recurrence1. Due to factors such as decreased quality of life, growing antibiotic resistance, and increased treatment costs, studying and developing new management strategies with non-antibiotic therapies is much in need. Here, we aim to study the efficacy and safety of lactobacillus in the treatment of recurrent UTIs. |