Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

Sponsor

Associate Prof. Ljubomir Petricevic MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04778722

Collaborator

(none)

Enrollment

Location

Arm

8.5

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Infection Genitourinary System	Dietary Supplement: Oral probiotics	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Receiving Oral ProbioticsReceiving Oral Probiotics

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

CST [14 Days]
change of vaginal microbiome after probiotic intake

Secondary Outcome Measures

Lactobacilli Change [14 Days]
change of relative abundances of each Lactobacillus species contained in the probiotic

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Associate Prof. Ljubomir Petricevic MD

Investigators

Principal Investigator: Ljubomir Petricevic, Prof Dr, Medical University Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Associate Prof. Ljubomir Petricevic MD, principal investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04778722

Other Study ID Numbers:

LP2021/INF1.1

First Posted:

Mar 3, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Associate Prof. Ljubomir Petricevic MD, principal investigator, Medical University of Vienna

probiotics

pregnant women

microbiome

Additional relevant MeSH terms:

Pregnancy Complications, Infectious

Study Results

No Results Posted as of Dec 17, 2021