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A clinical study evaluating the effectiveness of Lactobacillus
vaginal suppositories in patients with recurrent urinary tract infection (A study evaluating the effectiveness of Lactobacillus vaginal suppositories in recurrent urinary tract infection)

Effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection (Effectiveness of Lactobacillus vaginal suppositories in recurrent urinary tract infection)

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It was performed on 28 female outpatients who were aged over 20 years, and 21 cases could be followed up during the 1 year after the final suppository administration. The mean patient age was 68.3 years (from 42 to 85 years). Of the 21 cases, acute simple cystitis was 18 cases and chronic complicated cystitis was 3 cases.

In the process of producing Lactobacillus vaginal suppositories, freeze-drying was outsourced to an external organization, but it became difficult to outsource to the same organization in the future, and it became impossible to produce the same Lactobacillus vaginal suppositories as before. The study was discontinued on October 26, 2020. The target was 50, but at the time of cancellation, the number of consents was 28, the number of cancellations was 3, and the number of completions was 25. Of these, 21 were eligible.

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The primary end-point The response rate, as assessed by the number of episodes of recurrent cystitis during the year of administration Result: A total of 28 women were enrolled, and 21 completed the study. During the period of suppository administration, 9 of the 21 (43 %)patients achieved a remarkably effective response(cases that could be suppressed by 70 % or more), 18 of the 21 patients (86 %) reported an effective response. The secondary end-points 1.The response rate, as assessed by episodes of recurrent cystitis during the 1 year after completion of the administration period 2.The total number of episodes of recurrent cystitis before, during and after administration 3. Changes in urine bacteria and the vaginal microbiome 4.Adverse events Result: 1.During the 1 year after the final suppository administration, 13 of the 21 (62%)patients achieved a remarkably effective response(cases that could be suppressed by 70 % or more), 16 of the 21 patients (77 %) reported an effective response. 2. There was a significant reduction in the mean number of episodes of cystitis, both during and after administration of Lactobacillus vaginal suppositories(P=0.00054,0.00007). 3. Before vaginal suppository administration, Escherichia coli was isolated from the urinary tract in 17 cases. Intestinal bacteria were isolated from the vagina at the start of administration in 7 patients. At the time of acute cystitis, the same type of bacteria was detected in the urinary tract and vagina in 9 cases. Amplicon sequencing analysis of the vaginal microbiome showed that Lactobacillus species colonized the vagina during the periods when episodes of cystitis were absent. 4.No treatment-related adverse events were observed.

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.

Jan. 12, 2022

July. 13, 2021

https://pubmed.ncbi.nlm.nih.gov/34258813/

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https://jrct.mhlw.go.jp/latest-detail/jRCTs061180053

ISHII AYANO

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

ishii-a@cc.okayama-u.ac.jp

ISHII AYANO

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

+81-86-235-7287

ishii-a@cc.okayama-u.ac.jp

Complete

Dec. 01, 2013

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

prevention purpose

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)

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

Female

Recurrent urinary tract infection

For 1 year, Lactobacillus vaginal supposite is inserted into the vagina once every 2 days or 3 times a week before going to bed.

Urinary tract infection

Response rate of Lactobacillus vaginal supposite in 1 year during administration

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

+81-86-235-7133

Feb. 28, 2019

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