Recurrent Urinary Tract Infection in Adult Women
Conditions
Brief summary
Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime. The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.
Detailed description
This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently treated for UTI. Primary objective The primary objective is to evaluate the effect of oral supplementation with probiotic on the frequency of UTI during six months from start of intervention in adult women with recurrent UTI.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic
Sponsors
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
double-blinded, randomized, placebo-controlled, parallel-group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to give informed consent for participation in the study. 2. Woman aged 18-50 years old at screening. 3. BMI ≥18 at screening. 4. Currently on antibiotic treatment for UTI, at the time of screening. Antibiotic treatment must stop within three days prior to first IP dose. 5. Recurrent UTI defined as at least two UTIs during the last six months or at least three UTIs during the last 12 months, according to information given by the subject. 6. Able and willing to comply with the restrictions defined for the the study period (see Section 10.6). 7. Access to Bank ID and ability to use the e-health platform (i.e. Internet access). 8. Ability to understand and comply with the requirements of the study, as judged by the Investigator.
Exclusion criteria
1. Postmenopausal (defined as 12 months of amenorrhoea). 2. Pregnant or breastfeeding. 3. Planning to become pregnant during the study. 4. Irregular menstruations combined with perimenopausal symptoms. 5. Known hypersensitivity or allergy to any of the components of the test product, or to the comparator (placebo). 6. Use of spermicide contraceptives including spermicidal condom within three days prior to first IP dose. 7. History of complicated cystitis, urgency incontinence, recent pyelonephritis, urological and/or gynaecologist abnormalities, immunocompromised, as judged by the Investigator. 8. Unstable bowel disorder such as diarrhoea, Crohn's disease, ulcerative colitis. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. | 6 months | Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability | 6 month | Mean number of confirmed UTIs during the three months intervention period, as compared to placebo. Mean number of confirmed UTIs during the three months follow-up period, as compared to placebo. Mean time from start of intervention to first relapse of UTI, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during three months from start of intervention, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during six months from start of intervention, as compared to placebo. Occurrence and frequency of Adverse Events (AEs). |
Countries
Sweden
Participant flow
Pre-assignment details
One of the participants randomised to the placebo group did not start the intervention, therefore it is a discrepancy between the planned and actual number of started participants.
Participants by arm
| Arm | Count |
|---|---|
| Active Probiotics | 65 |
| Placebo Placebo Control Group | 67 |
| Total | 132 |
Baseline characteristics
| Characteristic | Active | Placebo | Total |
|---|---|---|---|
| Age, Customized | 30.1 years STANDARD_DEVIATION 8 | 31.2 years STANDARD_DEVIATION 9.3 | 30.7 years STANDARD_DEVIATION 8.7 |
| Body Mass Index | 23.7 kg/m^2 STANDARD_DEVIATION 3.7 | 23.7 kg/m^2 STANDARD_DEVIATION 4.4 | 23.7 kg/m^2 STANDARD_DEVIATION 4.1 |
| Height | 166.4 cm STANDARD_DEVIATION 5.4 | 167.2 cm STANDARD_DEVIATION 6.5 | 166.8 cm STANDARD_DEVIATION 5.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 64 Participants | 128 Participants |
| Region of Enrollment Sweden | 65 participants | 67 participants | 132 participants |
| Sex: Female, Male Female | 65 Participants | 67 Participants | 132 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| weight | 65.7 kg STANDARD_DEVIATION 10.9 | 66.2 kg STANDARD_DEVIATION 12.7 | 65.9 kg STANDARD_DEVIATION 11.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 69 |
| other Total, other adverse events | 36 / 70 | 36 / 69 |
| serious Total, serious adverse events | 0 / 70 | 3 / 69 |
Outcome results
Primary
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
Mean number (Standard Deviation) of confirmed UTIs in adult women with recurrent UTI, during six months from start of intervention, as compared to placebo.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. | 1.2 Number of unique UTIs during study | Standard Deviation 1.4 |
| Placebo | To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. | 1.3 Number of unique UTIs during study | Standard Deviation 1.3 |
Secondary
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the -Frequency of Confirmed UTI -Time to First Relapse of UTI. -Relapse Rate -Assess the Tolerability
Mean number of confirmed UTIs during the three months intervention period, as compared to placebo. Mean number of confirmed UTIs during the three months follow-up period, as compared to placebo. Mean time from start of intervention to first relapse of UTI, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during three months from start of intervention, as compared to placebo. Proportion of subjects (%) who experienced at least one confirmed UTI during six months from start of intervention, as compared to placebo. Occurrence and frequency of Adverse Events (AEs).
Time frame: 6 month