Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women

NCT03366077 | Completed Results

• 1 other identifier: CSUB0144
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Urinary Tract Infection in Adult Women

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  6 month

Study Arms (2)

Active

ACTIVE COMPARATOR

L reuteri

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Healty women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioGaia AB: lead

Study Sites (1)

Clinical Trial Consultants AB

Uppsala, 752 37, Sweden

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Jenny Palming Clinical research Director
• Organization: BioGaia AB

jp@biogaia.se

+46 738299900

Study Officials

• Erik Rein-Hedin, MD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blinded, randomized, placebo-controlled, parallel-group

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: December 13, 2017
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)