Effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infectio

Phase 2

• Conditions: Recurrent urinary tract infection; Urinary tract infection

• Registration Number: JPRN-jRCTs061180053
• Lead Sponsor: ISHII AYANO

Brief Summary

Patients with recurrent cystitis were instructed to insert one vaginal suppository for 1 year. 21 completed the study. The mean patient age was 68.3. The number of recurrences of cystitis could be suppressed by 70% or more were 9 of the 21(43%) patients and 13 (62%) patients, during and after administration each other.The median number of recurrences of urinary tract infections was a significant reduction . In some cases, L. crispatus could be confirmed from the vagina. No adverse events were observed.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-14
• Study Completion: 2020-09-27
• Results First Posted: 2021-07-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

1) Acute simple cystitis
2) Acute exacerbation of chronic complicated cystitis occurring in patients using clean intermittent catheterization
3) Acute exacerbation of chronic complicated cystitis in neurogenic bladder and overactive bladder with residual urine volume of 50 mL or less
4) Other acute exacerbations of chronic complicated cystitis occurred in mild basic disease of the urinary tract
The episode of urinary tract infection in need of intervention corresponding to any one of the above 1) to 4) has been found twice or more in the recent 1 year and the female patients of below 1) to 3)
1) Patients who have already completed treatment with urinary tract infection antibiotics
2) Patients over 20 years old
3) Outpatient(Non-hospitalized patient)

Exclusion Criteria

1) Patients requiring urological treatment such as urolithiasis, hydronephrosis, urinary tract tumors
2) Patient indwelling urethral catheter
3) Patients with severe underlying disease and complications such as poorly controlled diabetes, collagen disease, leukemia, advanced cancer, congestive heart failure, severe liver or renal dysfunction
4) Patients who had seen allergic hypersensitivity symptoms by ingestion of dairy products or lactobacillus products in the past
5) Patients who have sex partner, whose partner have had allergic hypersensitivity symptoms by ingestion of dairy products or lactobacillus products in the past
6) Patients who wish to have babies within one year and patients who are pregnant
7) Patients who were judged inappropriate as subjects of this study by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate of Lactobacillus vaginal supposite in 1 year during administration

Secondary Outcome Measures

Name	Time	Method
1)Response rate of Lactobacillus vaginal supposite in 1 year after completion of administration<br>2)Number of recurrence of urinary tract infection (1 year during administration and 1 year after completion of administration)<br>3)Changes in urine and vaginal separating bacteria<br>4)Adverse event