Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pregnancy; Infection Genitourinary System
Type
Interventional
Phase
Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Receiving Oral ProbioticsMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

Although the research of the vaginal microbiome is taking faster pace in recent years than it was the case before, there is still lack of information, about its composition, how and when it changes and how that can affect processes in the female body. During pregnancy, the microbiome physiologically...

Although the research of the vaginal microbiome is taking faster pace in recent years than it was the case before, there is still lack of information, about its composition, how and when it changes and how that can affect processes in the female body. During pregnancy, the microbiome physiologically gets increasingly stable. Diversity of bacteria decreases, which is the sign of a healthy microbiome, and Lactobacillus species increase their already pre-existing dominance. Acidic metabolites of those bacteria maintain the low pH and low diversity in vagina. If the dominance of lactobacilli is not as large as it should be, the risk of preterm birth increases significantly. Low relative abundance of Lactobacillus species, especially Lactobacillus crispatus (marker of the healthy microbiome) and lactobacillus metabolites as well as high vaginal microbial diversity are most significantly connected with preterm birth. Despite such a high relevance of vaginal microbiome for a healthy pregnancy, and for women's health in general, there's an insufficient proof that the intake of oral probiotics can change it. The aim of our study is to see if the intake of patented dietary supplement, containing four Lactobacillus strains can change the relative abundance of different bacteria in the vaginal microbiome. This could lay ground for further research in this area and even create new therapeutic approaches in the future.

Tracking Information

NCT #
NCT04778722
Collaborators
Not Provided
Investigators
Principal Investigator: Ljubomir Petricevic, Prof Dr Medical University Vienna