Health Condition 1: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: Cap Provinorm: 1. Composition:
Cap Provinorm is as follows:
i. Lactobacillus acidophilus UBLA-34: 2 billion
ii. Lactobacillus rhamnosus UBLR-58: 2 billion
iii. Lactobacill
Sponsors
Unique Biotech Linited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. PRIMARY OBJECTIVE Mean number of confirmed UTIs (either clinical or bacteriological or both) during 24 weeks from start of intervention, as compared to placebo. Timepoint: 0 week Screening eligibility and enrollment followed by evaluations at 4. 8 12 16, 20 and 24 weeks (Last visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| i. To determine time from randomization to first clinical UTI. ii.To report and compare any adverse drug reactions observed in the probiotic versus placebo groups. Timepoint: 0 week Screening eligibility and enrollment followed by evaluations at 4. 8 12 16, 20 and 24 weeks (Last visit) | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS, Bhubaneswar
Outcome results
None listed