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

JRCT ID: jRCTs061180053

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Recurrent urinary tract infection
• Date of first enrollment: 03/02/2014
• Target sample size: 50
• Study type: Interventional
• Intervention(s): For 1 year, Lactobacillus vaginal supposite is inserted into the vagina once every 2 days or 3 times a week before going to bed.

Outcome(s)

• Primary Outcome: Response rate of Lactobacillus vaginal supposite in 1 year during administration

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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)

Exclude 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

Related Information

• Primary Sponsor: ISHII AYANO
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology,Management Expenses Grants
• Secondary ID(s): UMIN000015476