Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

Not Applicable

Recruiting

• Conditions: Pregnancy; Infection Genitourinary System
• Interventions: Dietary Supplement: Oral probiotics

• Registration Number: NCT04778722
• Lead Sponsor: Associate Prof. Ljubomir Petricevic MD

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.

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-28
• Study First Posted: 2021-03-03
• Study Start: 2022-08-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2023-04-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic group	Oral probiotics	pilot study with one interventional group

Primary Outcome Measures

Name	Time	Method
CST	14 Days	change of vaginal microbiome after probiotic intake

Secondary Outcome Measures

Name	Time	Method
Lactobacilli Change	14 Days	change of relative abundances of each Lactobacillus species contained in the probiotic

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Medical University of Vienna; 🇦🇹 Vienna, Austria