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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04778722
Enrollment
44
Registered
2021-03-03
Start date
2022-08-15
Completion date
2023-05-01
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy; Infection Genitourinary System

Keywords

probiotics, pregnant women, microbiome

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.

Interventions

DIETARY_SUPPLEMENTOral probiotics

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

Sponsors

Associate Prof. Ljubomir Petricevic MD
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Receiving Oral Probiotics

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CST14 Dayschange of vaginal microbiome after probiotic intake

Secondary

MeasureTime frameDescription
Lactobacilli Change14 Dayschange of relative abundances of each Lactobacillus species contained in the probiotic

Countries

Austria

Contacts

Primary ContactLjubomir Petricevic, Prof Dr
Ljubomir.petricevic@meduniwien.ac.at4314040028220
Backup ContactPhilipp Pappenscheller
philipp.pappenscheller@meduniwien.ac.at4314040028220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026