Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT05590195
Eligibility Criteria:
Inclusion Criteria:
* Female
* 18-45 years old premenopausal (period within 6 months)
* Nugent score of 4-6 (intermediate) or 7-10 (BV)
* Have an ability to collect a clean urine sample
* Prescription and over the counter medication unchanged for \> 30 days prior to the study. -Participants who are taking medications as needed (PRN) may be included if they began PRN usage \>30 days prior to baseline
* Sexually active status of the participants can be either active or inactive
* Participants must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have negative pregnancy test results at screening and baseline
Exclusion Criteria:
* Faecal incontinence
* History of urinary fistula, bladder or kidney stones, interstitial cystitis, or cystoscopic abnormalities that could be malignant
* Neurogenic bladder
* A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
* Antibiotic and/or anti-fungal medication used within the last four weeks
* Oral probiotic supplement use within 2 weeks prior the study excluding yogurt
* Drug abuse
* Uncontrolled psychological disorders
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05590195
Study Brief:
Protocol Section:
NCT05590195