Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Infection Genitourinary System
• Intervention / Treatment: Dietary supplement: Oral probiotics

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ljubomir Petricevic, Prof Dr; Phone Number: 4314040028220; Email: Ljubomir.petricevic@meduniwien.ac.at
• Study Contact Backup: Name: Philipp Pappenscheller; Phone Number: 4314040028220; Email: philipp.pappenscheller@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Obstetrics and Gynecology, Medical University of Vienna
    • Principal Investigator: Ljubomir Petricevic, Prof. M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic group; pilot study with one interventional group	Dietary supplement: Oral probiotics; containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CST	change of vaginal microbiome after probiotic intake	14 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactobacilli Change	change of relative abundances of each Lactobacillus species contained in the probiotic	14 Days

Collaborators and Investigators

• Sponsor: Associate Prof. Ljubomir Petricevic MD
• Investigators: Principal Investigator: Ljubomir Petricevic, Prof Dr, Medical University Vienna

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (ACTUAL): March 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: probiotics; pregnant women; microbiome
• Additional Relevant MeSH Terms: Infections; Pregnancy Complications; Pregnancy Complications, Infectious
• Other Study ID Numbers: LP2021/INF1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No