NCT05553652 The Effect of ASTARTE™ on Recurrent Urinary Tract Infection
| NCT ID | NCT05553652 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hvidovre University Hospital |
| Condition | Recurrent Urinary Tract Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 720 participants |
| Start Date | 2022-09-19 |
| Primary Completion | 2024-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 720 participants in total. It began in 2022-09-19 with a primary completion date of 2024-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Andreas Petersen, DM. PhD
PRINCIPAL INVESTIGATOR
Hvidovre Hospital, University of Copenhagen
Frequently Asked Questions
Who can join the NCT05553652 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Recurrent Urinary Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05553652 currently recruiting?
Yes, NCT05553652 is actively recruiting participants. Contact the research team at andreas.munk.petersen@regionh.dk for enrollment information.
Where is the NCT05553652 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT05553652 clinical trial?
NCT05553652 is sponsored by Hvidovre University Hospital. The principal investigator is Andreas Petersen, DM. PhD at Hvidovre Hospital, University of Copenhagen. The trial plans to enroll 720 participants.