Effect of ASTARTE™ Probiotic on Recurrent Urinary Tract Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.