Trial on Probiotics in Prevention of repeated Urinary Tract Infection in Adult Wome
- Conditions
- Health Condition 1: N328- Other specified disorders of bladder
- Registration Number
- CTRI/2019/04/018434
- Lead Sponsor
- nique Biotech Linited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
i.Women of 18-50 years of age who have not attained menopause
ii.Women with an active episode of recurrent UTI
iii.Recurrent UTI defined as:
a)More than 2 symptomatic, culture-proven UTI over past 6 months OR
b)More than 3 symptomatic, culture-proven UTI over past 12 months
iv.Willing to give informed consent for the study
i.Polycystic disease, interstitial cystitis, previous urological surgery, stones, or anatomical abnormalities of the urinary tract
ii.Pregnant or breastfeeding or planning a pregnancy in the next 6 months
iii.Known allergy or intolerance to any of the study products
iv.A history of renal stones and/or renal transplantation
v.Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
vi.Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
vii.Intermittent or indwelling catheterization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method I. PRIMARY OBJECTIVE <br/ ><br>Mean number of confirmed UTIs (either clinical or bacteriological or both) during 24 weeks from start of intervention, as compared to placebo. <br/ ><br> <br/ ><br>Timepoint: 0 week Screening eligibility and enrollment followed by evaluations at <br/ ><br>4. <br/ ><br>8 <br/ ><br>12 <br/ ><br>16, <br/ ><br>20 and 24 weeks (Last visit) <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method i. To determine time from randomization to first clinical UTI. <br/ ><br>ii.To report and compare any adverse drug reactions observed in the probiotic versus placebo groups. <br/ ><br>Timepoint: 0 week Screening eligibility and enrollment followed by evaluations at <br/ ><br>4. <br/ ><br>8 <br/ ><br>12 <br/ ><br>16, <br/ ><br>20 and 24 weeks (Last visit)