NCT04778722

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

February 23, 2021

Last Update Submit

November 14, 2022

Conditions

Pregnancy; Infection Genitourinary System

Keywords

probioticspregnant womenmicrobiome

Outcome Measures

Primary Outcomes (1)

  • CST

    change of vaginal microbiome after probiotic intake

    14 Days

Secondary Outcomes (1)

  • Lactobacilli Change

    14 Days

Study Arms (1)

Probiotic group

EXPERIMENTAL

pilot study with one interventional group

Dietary Supplement: Oral probiotics

Interventions

Oral probioticsDIETARY_SUPPLEMENT

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

Probiotic group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFirst trimester Pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ljubomir Petricevic, Prof Dr

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ljubomir Petricevic, Prof Dr

CONTACT

4314040028220Ljubomir.petricevic@meduniwien.ac.at

Philipp Pappenscheller

CONTACT

4314040028220philipp.pappenscheller@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Receiving Oral Probiotics
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 3, 2021

Study Start

August 15, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)