Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

Associate Prof. Ljubomir Petricevic MD

Status: Enrolling

Conditions: Pregnancy; Infection Genitourinary System

Treatments: Dietary Supplement: Oral probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04778722

LP2021/INF1.1

Details and patient eligibility

About

Change of Vaginal microbiome in first trimester pregnant women after oral intake of Probiotic preparation with 4 lactobacilli strains

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Probiotic group

Experimental group

Description:

pilot study with one interventional group

Treatment:

Dietary Supplement: Oral probiotics