Recurrent Urinary Tract InfectionrUTINCT05553652
The Effect of ASTARTE™ on Recurrent Urinary Tract Infection
A study testing ASTARTE™ oral capsules in people with Recurrent Urinary Tract Infection, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- ASTARTE™ oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2022to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, 2650
Andreas M Petersen, MD, ph.d, 004538625960, andreas.munk.petersen@regionh.dk
Khaled Ghathian, ph.d. stud., +4538623205, kgha0001@regionh.dk
About this study
Official title: 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
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.
Read the detailed description
Urinary tract infection (UTI) is one of the most common infections, contributing to increased antibiotic consumption and high costs. Women are often developing UTI due to the anatomically short distance from the rectum opening to the urethra. There is a risk of serious complications associated with pregnancy, where there is an increased risk of developing pelvic inflammatory disease and premature birth. This will in some cases lead to increased risk of maternal and neonatal morbidity and mortality; especially in infection with Streptococcus agalactiae. Recurrent UTI (rUTI) with urease producing microorganisms such as Proteus and Klebsiella will cause an increased risk of developing stones in the urinary tract.
Scientific studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. Probiotics are non-pathogenic microorganisms capable of affecting gastrointestinal microbiota with a change in microbiota composition, thus increasing the production of beneficial substances when ingested in appropriate quantities. The consumption of probiotics is not considered to be associated with adverse reactions to humans because they are usually found naturally in e.g. gastrointestinal and vaginal microbiota.
A prospective study over 2-years which is conducted as a randomized placebo-controlled double-blind study. In this study the investigators will investigate the effect of probiotics ASTARTE™ ( Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii, Lactobacillus gasseri) on the composition of bacteria in urine, faces and vagina, and a possible reduction of risk factors for development of rUTI in women (18 to 40 years). The investigators will map the microbiota in the faeces and vagina and examine if there are a relationship between colonization of the urinary tract with pathogens and the composition of the intestinal and vaginal microbiota.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- ASTARTE™ oral capsules, Placebo oral capsules
- Keywords
- rUTI, Probiotic
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTARTE™ oral capsulesDietary supplement
1 Capsule daily for 6 months
Placebo oral capsulesDietary supplement
1 Capsule daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| ASTARTE™ oral capsule | Active comparator | The capsule will contain a mixture of four probiotic strains with a combined potency of 5 x10^9 (CFU)/capsule:
Lactobacillus crispatus LBV88, 2 x10^9 CFU/g Lactobacillus rhamnosus LBV96, 2 x10^9 CFU/g Lactobacillus gasseri LBV150N , 0.6 x10^9 CFU/g Lactobacillus jensenii LBV116, 0.4 x10^9 CFU/g Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg Receives: Dietary Supplement: ASTARTE™ oral capsules; Dietary Supplement: Placebo oral capsules |
| Placebo oral capsule | Placebo comparator | The placebo oral capsules is identical to the ASTARTE™ capsules and contains Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg Receives: Dietary Supplement: ASTARTE™ oral capsules; Dietary Supplement: Placebo oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of UTI cases
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.
Measured: 6 months
Secondary outcomes (4)
Number of UTI after intervention
Number of symptomatic urinary tract infection cases during the intervention compared to the number of UTI cases after the intervention. Measured from a urine sample.
Measured: 12 months
UTI symptoms
Change in UTI symptoms from the baseline measure by the ICIQ-FLUTS questionnaire every 2d months. We measure score values:
0-16 filling symptoms subscale, 0-12 voiding symptoms subscale, 0-20 incontinence symptoms subscale
Measured: 12 months
Change of vaginal microbiome
Change in vaginal microbiome from the baseline measure by Microbiome genetic test. Measure from a feacal sample every 2d month in the intervention period.
Measured: 6 months
Change of gut microbiome
Change in gut microbiome from the baseline measure by Microbiome genetic test. Measure from a fecal sample every 2d month in the intervention period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start19 Sep 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Andreas Petersen, DM. PhD, Principal investigator, Hvidovre Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553652
- Sponsor's protocol ID
- H-22014666
- Acronym
- rUTI
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghathian KSA, Halkjaer SI, Krogfelt KA, Frimodt-Moller N, Hansen KH, Frederiksen AKS, Holm A, Petersen AM. The effect of the probiotic supplement-ASTARTE-on the reduction of recurrent urinary tract infection in women aged 18-40 years: protocol for a randomized, double-blind, placebo-controlled study. Trials. 2026 Apr 7;27(1):383. doi: 10.1186/s13063-026-09679-3.
PubMed 41943076
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05553652
- Acronym / sponsor ID
- rUTI / H-22014666
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- rUTI, Probiotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Urinary tract infection (UTI) is one of the most common infections, contributing to increased antibiotic consumption and high costs. Women are often developing UTI due to the anatomically short distance from the rectum opening to the urethra. There is a risk of serious complications associated with pregnancy, where there is an increased risk of developing pelvic inflammatory disease and premature birth. This will in some cases lead to increased risk of maternal and neonatal morbidity and mortality; especially in infection with Streptococcus agalactiae. Recurrent UTI (rUTI) with urease producing microorganisms such as Proteus and Klebsiella will cause an increased risk of developing stones in the urinary tract.
Scientific studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. Probiotics are non-pathogenic microorganisms capable of affecting gastrointestinal microbiota with a change in microbiota composition, thus increasing the production of beneficial substances when ingested in appropriate quantities. The consumption of probiotics is not considered to be associated with adverse reactions to humans because they are usually found naturally in e.g. gastrointestinal and vaginal microbiota.
A prospective study over 2-years which is conducted as a randomized placebo-controlled double-blind study. In this study the investigators will investigate the effect of probiotics ASTARTE™ ( Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii, Lactobacillus gasseri) on the composition of bacteria in urine, faces and vagina, and a possible reduction of risk factors for development of rUTI in women (18 to 40 years). The investigators will map the microbiota in the faeces and vagina and examine if there are a relationship between colonization of the urinary tract with pathogens and the composition of the intestinal and vaginal microbiota.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASTARTE™ oral capsule | Active comparator | Dietary Supplement: ASTARTE™ oral capsules, Dietary Supplement: Placebo oral capsulesThe capsule will contain a mixture of four probiotic strains with a combined potency of 5 x10^9 (CFU)/capsule: Lactobacillus crispatus LBV88, 2 x10^9 CFU/g Lactobacillus rhamnosus LBV96, 2 x10^9 CFU/g Lactobacillus gasseri LBV150N , 0.6 x10^9 CFU/g Lactobacillus jensenii LBV116, 0.4 x10^9 CFU/g Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg |
| Placebo oral capsule | Placebo comparator | Dietary Supplement: ASTARTE™ oral capsules, Dietary Supplement: Placebo oral capsulesThe placebo oral capsules is identical to the ASTARTE™ capsules and contains Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASTARTE™ oral capsules1 Capsule daily for 6 months | Dietary supplement | ASTARTE™ oral capsule, Placebo oral capsule |
| Placebo oral capsules1 Capsule daily for 6 months | Dietary supplement | ASTARTE™ oral capsule, Placebo oral capsule |
Primary outcome
Reduction of UTI cases
Time frame: 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.
4 secondary outcomes
Number of UTI after intervention
Time frame: 12 months
UTI symptoms
Time frame: 12 months
Change of vaginal microbiome
Time frame: 6 months
Change of gut microbiome
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 41943076Ghathian KSA, Halkjaer SI, Krogfelt KA, Frimodt-Moller N, Hansen KH, Frederiksen AKS, Holm A, Petersen AM. The effect of the probiotic supplement-ASTARTE-on the reduction of recurrent urinary tract infection in women aged 18-40 years: protocol for a randomized, double-blind, placebo-controlled study. Trials. 2026 Apr 7;27(1):383. doi: 10.1186/s13063-026-09679-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Petersen, DM. PhD principal investigator
Hvidovre Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASTARTE™ oral capsules in people with Recurrent Urinary Tract Infection, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Petersen, DM. PhD (+4538626199, andreas.munk.petersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of UTI cases (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.