Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

Pregnancy; Infection Genitourinary System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778722
• Other study ID #: LP2021/INF1.1
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2022
• Source: Medical University of Vienna
• Contact: Ljubomir Petricevic, Prof Dr
• Phone: 4314040028220
• Email: Ljubomir.petricevic[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications, Infectious
• Pregnancy; Infection Genitourinary System

Intervention

Dietary Supplement:
• Oral probiotics
containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)

Locations

Country	Name	City	State
Austria	Department of Obstetrics and Gynecology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Associate Prof. Ljubomir Petricevic MD

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CST	change of vaginal microbiome after probiotic intake	14 Days
Secondary	Lactobacilli Change	change of relative abundances of each Lactobacillus species contained in the probiotic	14 Days