Effect of ASTARTE™ Probiotic on Recurrent Urinary Tract Infections
The Effect of ASTARTE™; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women
This study is testing if a special probiotic can help women aged 18-40 who keep getting urinary tract infections feel better and have fewer symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre, Copenhagen) |
| Trial ID | NCT05553652 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of the probiotic ASTARTE™, which contains specific strains of Lactobacillus, on the microbiome composition in women aged 18-40 years who experience recurrent urinary tract infections (rUTIs). Over a 6-month period, participants will receive either the probiotic or a placebo in a randomized, double-blind, placebo-controlled design. The primary outcome will be the incidence of symptomatic UTIs, aiming to determine if the probiotic can effectively reduce the risk factors associated with rUTIs. The study seeks to provide insights into the potential benefits of dietary supplements in managing recurrent infections.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 who have experienced recurrent urinary tract infections.
Not a fit: Patients who are pregnant, breastfeeding, or have hypersensitivity to any ingredients in the study product may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-antibiotic approach to reducing the incidence of recurrent urinary tract infections in women.
How similar studies have performed: Previous studies have suggested that probiotics can effectively reduce the risk of infections, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women 18-40 years of age * Recurrent UTI (2 times UTI within 6 months or \> 3 times UTI infection within one year). * The subjects should be informed about the trial protocol. * The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent. Exclusion Criteria: * Pregnancy or planning pregnancy * Breastfeeding * Participation in another trial with probiotic the last 30 days. * Hypersensitivity to any ingredient in the study product * Patients primarily admitted for a disorder other than UTI * Antibiotic treatment for any other condition than UTI at time of recruitment the last 30 days
Where this trial is running
Hvidovre, Copenhagen
- Gastrounit, Copenhagen University Hospital Hvidovre — Hvidovre, Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Andreas Petersen, DM. PhD — Hvidovre Hospital, University of Copenhagen
- Study coordinator: Andreas Petersen, DM. PhD
- Email: andreas.munk.petersen@regionh.dk
- Phone: +4538626199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.