Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.
Primary Purpose
Pregnancy; Infection Genitourinary System
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Oral probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy; Infection Genitourinary System focused on measuring probiotics, pregnant women, microbiome
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
Sites / Locations
- Department of Obstetrics and Gynecology, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probiotic group
Arm Description
pilot study with one interventional group
Outcomes
Primary Outcome Measures
CST
change of vaginal microbiome after probiotic intake
Secondary Outcome Measures
Lactobacilli Change
change of relative abundances of each Lactobacillus species contained in the probiotic
Full Information
NCT ID
NCT04778722
First Posted
February 23, 2021
Last Updated
November 14, 2022
Sponsor
Associate Prof. Ljubomir Petricevic MD
1. Study Identification
Unique Protocol Identification Number
NCT04778722
Brief Title
Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.
Official Title
Development of Microbiome Vaginae After Use of Oral Probiotics in First the Trimester of Pregnancy. A Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Associate Prof. Ljubomir Petricevic MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy; Infection Genitourinary System
Keywords
probiotics, pregnant women, microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Receiving Oral Probiotics
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
pilot study with one interventional group
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral probiotics
Intervention Description
containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)
Primary Outcome Measure Information:
Title
CST
Description
change of vaginal microbiome after probiotic intake
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Lactobacilli Change
Description
change of relative abundances of each Lactobacillus species contained in the probiotic
Time Frame
14 Days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
First trimester Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ljubomir Petricevic, Prof Dr
Phone
4314040028220
Email
Ljubomir.petricevic@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Pappenscheller
Phone
4314040028220
Email
philipp.pappenscheller@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ljubomir Petricevic, Prof Dr
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ljubomir Petricevic, Prof. M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.
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