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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05553652
Other study ID # H-22014666
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 19, 2022
Est. completion date December 1, 2027

Study information

Verified date September 2022
Source Hvidovre University Hospital
Contact Andreas Petersen, DM. PhD
Phone +4538626199
Email andreas.munk.petersen@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This is measured by the incidence of symptomatic UTI.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date December 1, 2027
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ASTARTE™ oral capsules
1 Capsule daily for 6 months
Placebo oral capsules
1 Capsule daily for 6 months

Locations

Country Name City State
Denmark Gastrounit, Copenhagen University Hospital Hvidovre Hvidovre Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
12 months
Secondary 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
Secondary 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
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