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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTARTE⢠oral capsules | Dietary Supplement | 1 Capsule daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| UTI symptoms |
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Inclusion Criteria:
Exclusion Criteria:
Women 18-40 years of age, Recurrent UTI (2 times UTI within 6 months or > 3 times UTI infection within one year).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Petersen, DM. PhD | Contact | +4538626199 | andreas.munk.petersen@regionh.dk | |
| Khaled Ghathian, phd.stud. | Contact | +38623205 | khaled.saoud.ali.ghathian@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Petersen, DM. PhD | Hvidovre Hospital, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrounit, Copenhagen University Hospital Hvidovre | Recruiting | Hvidovre | Copenhagen | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41943076 | Derived | 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. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo oral capsules | Dietary Supplement | 1 Capsule daily for 6 months |
|
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
| 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. | 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. | 6 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |