Clinical trial NCT04778722: Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.
Official title: Development of Microbiome Vaginae After Use of Oral Probiotics in First the Trimester of Pregnancy. A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy; Infection Genitourinary System
Keywords: probiotics
pregnant women
microbiome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Receiving Oral Probiotics
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CST
timeFrame: 14 Days
Secondary outcomes:
measure: Lactobacilli Change
timeFrame: 14 Days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Obstetrics and Gynecology, Medical University of Vienna
Study officials:
affiliation: Medical University Vienna
name: Ljubomir Petricevic, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: