Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.
Last updated on July 2021Recruitment
- 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