Status:
COMPLETED
Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women
Lead Sponsor:
BioGaia AB
Conditions:
Recurrent Urinary Tract Infection in Adult Women
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 cyst...
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...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent for participation in the study.
- Woman aged 18-50 years old at screening.
- BMI ≥18 at screening.
- Currently on antibiotic treatment for UTI, at the time of screening. Antibiotic treatment must stop within three days prior to first IP dose.
- 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.
- Able and willing to comply with the restrictions defined for the the study period (see Section 10.6).
- Access to Bank ID and ability to use the e-health platform (i.e. Internet access).
- Ability to understand and comply with the requirements of the study, as judged by the Investigator.
Exclusion
- Postmenopausal (defined as 12 months of amenorrhoea).
- Pregnant or breastfeeding.
- Planning to become pregnant during the study.
- Irregular menstruations combined with perimenopausal symptoms.
- Known hypersensitivity or allergy to any of the components of the test product, or to the comparator (placebo).
- Use of spermicide contraceptives including spermicidal condom within three days prior to first IP dose.
- History of complicated cystitis, urgency incontinence, recent pyelonephritis, urological and/or gynaecologist abnormalities, immunocompromised, as judged by the Investigator.
- Unstable bowel disorder such as diarrhoea, Crohn's disease, ulcerative colitis.
- \-
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03366077
Start Date
December 13 2017
End Date
July 12 2019
Last Update
September 15 2025
Active Locations (1)
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1
Clinical Trial Consultants AB
Uppsala, Sweden, 752 37