RECRUITINGINTERVENTIONAL
The Effect of ASTARTE™ on Recurrent Urinary Tract Infection
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIETARY_SUPPLEMENT
ASTARTE™ oral capsules
1 Capsule daily for 6 months
DIETARY_SUPPLEMENT
Placebo oral capsules
1 Capsule daily for 6 months
Locations (1)
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark