Clinical trial NCT03366077: Double-blinded, Randomized, Placebo-controlled Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Urinary Tract Infection in Adult Women
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded, randomized, placebo-controlled, parallel-group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Mean number of confirmed UTIs during six months from start of intervention, as compared to placebo
timeFrame: 6 M
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Clinical Trial Consultants AB
Study officials:
References: