Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

NCT ID: NCT04778722

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-05-01

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.

Conditions

Pregnancy; Infection Genitourinary System

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Probiotic group

pilot study with one interventional group

Group Type: EXPERIMENTAL

Oral probiotics

Intervention Type: DIETARY_SUPPLEMENT

containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)

Interventions

Oral probiotics

containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Associate Prof. Ljubomir Petricevic MD

OTHER

Sponsor Role: lead

Responsible Party

Associate Prof. Ljubomir Petricevic MD

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ljubomir Petricevic, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

Department of Obstetrics and Gynecology, Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Ljubomir Petricevic, Prof Dr

Role: CONTACT

Ljubomir.petricevic@meduniwien.ac.at

4314040028220

Philipp Pappenscheller

Role: CONTACT

philipp.pappenscheller@meduniwien.ac.at

4314040028220

Other Identifiers

LP2021/INF1.1

Identifier Type: -

Identifier Source: org_study_id