RecruitingNot ApplicableNCT05553652

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


Sponsor

Hvidovre University Hospital

Enrollment

720 participants

Start Date

Sep 19, 2022

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

DIETARY_SUPPLEMENTASTARTE™ oral capsules

1 Capsule daily for 6 months

DIETARY_SUPPLEMENTPlacebo oral capsules

1 Capsule daily for 6 months


Locations(1)

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, Denmark

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NCT05553652


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