Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

Study Overview
=================
Brief Summary
-----------------
Change of Vaginal microbiome in first trimester pregnant women after oral intake of Probiotic preparation with 4 lactobacilli strains

Detailed 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 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.

Official Title
-----------------
Development of Microbiome Vaginae After Use of Oral Probiotics in First the Trimester of Pregnancy. A Prospective Pilot Study

Conditions
-----------------
Pregnancy; Infection Genitourinary System

Intervention / Treatment
-----------------
* Dietary Supplement: Oral probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women aged between 18 and 45 infection screening during a prenatal consultation between 10+0 (10 weeks plus 0 days) and 16+0 (16 weeks plus 0 days) gestational weeks Singleton pregnancy Exclusion Criteria: Vaginal infections such as Bacterial vaginosis, candida vaginitis, trichomoniasis, mycoplasma, gonococcal infection Antibiotic therapy in the last 4 weeks Probiotic therapy in the last 4 weeks Operation on gastrointestinal tract Diarrhoea, obstipation Vaginal bleeding Patients with hormone disorders of any kind Other chronic diseases (Diabetes, Autoimmune diseases etc.) HIV Gestational diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Receiving Oral Probiotics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>pilot study with one interventional group | Dietary Supplement: Oral probiotics<br>* containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CST | change of vaginal microbiome after probiotic intake | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactobacilli Change | change of relative abundances of each Lactobacillus species contained in the probiotic | 14 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotics, pregnant women, microbiome