Back to resultsDouble-blinded, Randomized, Placebo-controlled Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection
Primary Purpose
Recurrent Urinary Tract Infection in Adult Women
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Urinary Tract Infection in Adult Women
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
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Sites / Locations
- Clinical Trial Consultants AB
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
L reuteri
Placebo
Outcomes
Primary Outcome Measures
Mean number of confirmed UTIs during six months from start of intervention, as compared to placebo
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03366077
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection in Adult Women
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blinded, randomized, placebo-controlled, parallel-group
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
L reuteri
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Probiotic
Primary Outcome Measure Information:
Title
Mean number of confirmed UTIs during six months from start of intervention, as compared to placebo
Time Frame
6 M
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Healty women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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Facility Information:
Facility Name
Clinical Trial Consultants AB
City
Uppsala
ZIP/Postal Code
752 37
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Double-blinded, Randomized, Placebo-controlled Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection
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