Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: Probiotic VHAKM-Akkermansia Muciniphila: Dose: Take one capsules or as
directed, best taken prior to a meal.
Frequency: One Capsule or as directed
Route of Administration: Oral
Total
Sponsors
Vidya Herbs Pvt LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Post-menopausal women are defined as greater than 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 greater or equal to 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit, 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. 3. Voluntarily participating in the clinical study, fully understanding, and being fully informed of the study, and having signed the Informed Consent Form. 4. Willingness and capability to complete all the study procedures.
Exclusion criteria
Exclusion criteria: 1. Immunosuppressants 2. Known allergies to investigational product or its excipients. 3. Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at the time of screening. 4. Women who have needed changes to medical intervention or in-office procedures in the last 3 months. 5. Women who wear a pessary. 6. Women who use catheters regularly. 7. 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. 8. Individuals that have a significant acute or chronic co-existing 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. 9. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Incidence rate of symptomatic UTITimepoint: ?Baseline (Day 01) ?Visit 05(Day 60): End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Change in the vaginal pH from baseline to Day 60 (end of study) ? The mean number of UTIs experienced per from baseline to Day 60 (end of study) ? Change in the FSH from baseline to Day 60 (end of study) ? Change in the LH from baseline to Day 60 (end of study) ? Change in the Serum estradiol levels from baseline to Day 60 (end of study) ? Change in the Serum testosterone levels from baseline to Day 60 (end of study) ? Change in the antral follicle count from baseline to Day 60 (end of study) ? Change in the ovarian volume from baseline to Day 60 (end of study) Timepoint: ?Baseline (Day 01) ?Visit 05(Day 60): End of Study | — |
Countries
India
Contacts
Public ContactDr Radha Parthasarathy
Srinivasan Rajalakshmi Memorial Hospital (SRMH)
Outcome results
None listed