ASTARTE™ oral capsules: 1 Capsule daily for 6 months
Placebo oral capsules: 1 Capsule daily for 6 months
Study summary
Investigate the effect of dietary supplements/probiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Reduction of UTI cases — 6 months Number of symptomatic urinary tract infection cases during the intervention compared to the number of UTI cases before the intervention (\> 2 UTIs per year). Measured from a urine sample.
Trial sites (1)
Facility
City
Region
Status
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre
Copenhagen
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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