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

Not Applicable

Completed

• Conditions: Recurrent Urinary Tract Infection in Adult Women
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT03366077
• Lead Sponsor: BioGaia AB

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.

Study Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2017-12-13
• Status Verified: 2018-03
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Probiotic	Placebo
Active	Probiotic	L reuteri

Primary Outcome Measures

Name	Time	Method
Mean number of confirmed UTIs during six months from start of intervention, as compared to placebo	6 M

Trial Locations

Locations (1)

Clinical Trial Consultants AB; 🇸🇪 Uppsala, Sweden