Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05553652
Status:
RECRUITING
Last Update Posted:
2022-09-23
First Post:
2022-09-16
Brief Title:
The Effect of ASTARTE on Recurrent Urinary Tract Infection
Sponsor:
Hvidovre University Hospital
Organization:
Hvidovre University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rUTI
Brief Summary:
Investigate the effect of dietary supplementsprobiotic 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None