Probiotics to reduce the incidence of recurrent urinary tract infections
- Conditions
- Health Condition 1: Z874- Personal history of diseases of genitourinary system
- Registration Number
- CTRI/2014/02/004425
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 176
1. Pre-menopausal women aged 18-45 years
2. History of three or more uncomplicated UTIs diagnosed in the past year, or two uncomplicated UTIs diagnosed in the past six months
3. Sterile urine culture at baseline
4. Agree for completion of screening procedures and agree to return for the subsequent follow up visits
5. Willing to insert vaginal tablet without an applicator
6. Capable of providing informed consent
7. Agree to abstain from self-medication with antibiotics for the UTI symptoms
8. Agree to abstain from antibiotic prophylaxis for recurrent UTI
9. Agree to abstain from the use of any other intra-vaginal product
10. Agree to abstain from sexual intercourse during 8 days course of vaginal tablet
1. All pregnant and lactating females
2. Those suffering from any disease of upper or lower urinary tract including pyelonephritis and UTI due to drug resistant strain
3. Patient with history of relapse of UTI within 2 wks, prior to starting the enrollment
4. Symptomatic bacterial vaginosis
5. Patients with immune-compromised status due to diseases like Diabetes/ AIDS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of administering VSL#3 & Florisia (oral & vaginal probiotic) and placebo on the microflora in females with recurrent UTI.Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method To evaluate the reduction in the incidence of symptomatic and probable UTI compared to placebo.Timepoint: 1 year