Evaluate the effecacy and safety of Probiotic on the clinical and biological parameters of women with urinary tract infection.

Phase 3

• Conditions: Health Condition 1: N399- Disorder of urinary system, unspecified

• Registration Number: CTRI/2024/03/064088
• Lead Sponsor: Vidya Herbs Pvt LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Post-menopausal women >12 months since their last menstrual period. Menopause may be natural or induced due to surgical or medical intervention.

2.Have a history of recurrent UTIs, defined as = 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit (Visit 1), at the discretion of the investigator. At least one episode must be diagnosed medically and treated by a health care professional, the remaining two may be self-reported.

Exclusion Criteria

Patients with history or significant presence of the following will be excluded from participation or enrollment in the study trial:

•Immunosuppressed

•Known allergies to investigational product or its excipients

•Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at time of screening

•Women who have needed changes to medical intervention or in-office procedures in the last 3 months

•Women who wear a pessary

•Women who use catheters regularly

•Women with an obstruction or neurogenic bladder causing incomplete bladder emptying. Individuals who have taken oral antibiotics (or topical antibiotics in their urogenital area) within the previous 30 days.

•Individuals that have a significant acute or chronic coexisting illness such as renal diseases (renal failure, nephrolithiasis), anatomical urinary tract abnormalities, intestinal disease, severe uncontrolled metabolic or cardiovascular disease (such as diabetes or hypertension), anticoagulant therapy, cancer.

•Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified