Recurrent Urinary Tract Infection in Adult WomenNCT03366077
Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women
A study testing Probiotic in people with Recurrent Urinary Tract Infection in Adult Women, run by BioGaia AB at 1 site in Sweden.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infection in Adult Women
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 13 Dec 2017to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | L reuteri Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start13 Dec 2017
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Urinary Tract Infection in Adult WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded, randomized, placebo-controlled, parallel-group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Rein-Hedin, MD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366077
- Sponsor's protocol ID
- CSUB0144
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2017
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03366077
- Acronym / sponsor ID
- CSUB0144
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blinded, randomized, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: ProbioticL reuteri |
| Placebo | Placebo comparator | Dietary Supplement: ProbioticPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotic | Dietary supplement | Active, Placebo |
Primary outcome
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI.
Time frame: 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.
1 secondary outcome
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
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Rein-Hedin, MD principal investigator
CTC Clinical Trial Consultants AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Recurrent Urinary Tract Infection in Adult Women, run by BioGaia AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Effect of Oral Supplementation With Lactobacillus Reuteri on the Frequency of Confirmed UTI in Adult Women With Recurrent UTI. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.