Double-blinded, Randomized, Placebo-controlled Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection

• ClinicalTrials.gov Identifier: NCT03366077
• Recruitment Status: Completed
• First Posted: December 8, 2017
• Last Update Posted: January 5, 2021
• Sponsor: BioGaia AB
• Information provided by (Responsible Party): BioGaia AB

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.

Condition or disease	Intervention/treatment	Phase
Recurrent Urinary Tract Infection in Adult Women	Dietary Supplement: Probiotic	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blinded, randomized, placebo-controlled, parallel-group
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: December 13, 2017
• Actual Primary Completion Date: July 12, 2019
• Actual Study Completion Date: July 12, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active; L reuteri	Dietary Supplement: Probiotic; Probiotic
Placebo Comparator: Placebo; Placebo	Dietary Supplement: Probiotic; Probiotic

Outcome Measures

Primary Outcome Measures :

1. Mean number of confirmed UTIs during six months from start of intervention, as compared to placebo [ Time Frame: 6 M ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Healty women
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

Sweden

Clinical Trial Consultants AB

Uppsala, Sweden, 752 37

Sponsors and Collaborators

BioGaia AB

More Information

• Responsible Party: BioGaia AB
• ClinicalTrials.gov Identifier: NCT03366077
• Other Study ID Numbers: CSUB0144
• First Posted: December 8, 2017
• Last Update Posted: January 5, 2021
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; Urinary Tract Infections; Disease Attributes; Pathologic Processes; Urologic Diseases