NIPH Clinical Trials Search

Study to Evaluate Whether Vaginal Application of Lactobacillus Can Prevent Recurrent Bladder Infections

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Recurrent urinary tract infection (recurrent cystitis)
Date of first enrollment	20/01/2026
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	A mixture of Lactobacillus and K-Y lubricating jelly will be prepared by a physician and administered intravaginally in the outpatient setting once a week for four weeks. The same regimen will be repeated two months later.

Outcome(s)

Primary Outcome

The primary outcome is the response rate to intravaginal Lactobacillus therapy during the six-month treatment period. Response is defined as a reduction of fifty percent or more in the number of acute cystitis episodes during the six-month treatment period compared with the six months before treatment. For example, if a participant had ten episodes of cystitis in the year before treatment and five or fewer episodes during the treatment year, the treatment will be considered effective. The proportion of patients meeting this criterion (response rate) will be evaluated.

Secondary Outcome

(1) Comparison of the number of acute cystitis episodes between the 6 months prior to treatment and the 6 months after completion of treatment. (2) Comparison of recurrent cystitis episodes between the 6-month treatment period and the 6 months after completion of treatment. (3) Changes in bacterial flora isolated from urine and vaginal samples. (4) Comparison with historical data from patients treated with intravaginal Lactobacillus suppository alone. (5) Changes from baseline in questionnaire-based assessments. (6) Incidence and nature of adverse events.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Female
Include criteria	(1) Patients whose urinary tract infection has been cured at the time of obtaining informed consent. (2) Patients who have experienced three or more episodes of acute uncomplicated cystitis requiring treatment within the past year, or two or more episodes within the past six months. (3) Postmenopausal women. (4) Outpatients (non-hospitalized patients). (5)Patients who are able to provide written informed consent for participation in the study.
Exclude criteria	(1) Patients with urological conditions requiring intervention, such as urinary stones, hydronephrosis, or urinary tract tumors. (2) Patients with an indwelling urethral catheter. (3) Patients with severe underlying diseases or complications, such as poorly controlled diabetes mellitus, collagen disease, leukemia, advanced cancer, congestive heart failure, or severe hepatic or renal dysfunction. (4) Patients who have experienced allergic or hypersensitivity reactions after consuming dairy products or Lactobacillus-containing products in the past. (5) Patients who are sexually active and whose partners have a history of allergic or hypersensitivity reactions after consuming dairy products or Lactobacillus-containing products. (6) Patients judged by the principal investigator or subinvestigators to be inappropriate for participation in this study.