CTRI/2019/04/018434
Not yet recruiting
Phase 3
Randomised, Double-Blind, Placebo- Controlled Trial Evaluating Safety and Efficacy of add-on Probiotic in Prevention of Recurrent Urinary Tract Infection in Adult Women
nique Biotech Linited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: N328- Other specified disorders of bladder
- Sponsor
- nique Biotech Linited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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