NCT02979288

Brief Summary

In the currently presented trial, investigators aim to evaluate the treatment of the intermediate vaginal microbiota during the first trimester of pregnancy with vaginal lactobacilli to restore the normal vaginal microbiota and therewith reduce the rate of PTD. All pregnant women between 10 + 0 (10 weeks plus 0 days) and 16 + 0 (16 weeks plus 0 days) gestational weeks in study group will be treated with vaginal Lactobacilli Capsules containing L. Casei rhamnosus LCR 35

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

November 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 24, 2021

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

November 28, 2016

Last Update Submit

February 23, 2021

Conditions

Lactobacillus Infection

Outcome Measures

Primary Outcomes (1)

  • the recovery to the normal vaginal microbiota (Nugent score 0 to 3).

    4 Weeks

Secondary Outcomes (1)

  • the gestational age at delivery, recorded as term delivery at or after 37 + 0 gestational weeks

    9 Months

Study Arms (4)

A Nugent 4 + Lactobacilli

EXPERIMENTAL

Intermediate vaginal Flora Nugent 4 with Lactobacilli. Intervention with vaginal probiotics with 'Lactobacillus casei rhamnosus (Lcr 35 regenerans)

Drug: Lactobacillus casei rhamnosus (Lcr 35 regenerans)

B Nugent 4 + Lactobacilli

ACTIVE COMPARATOR

Intermediate vaginal Flora Nugent 4 with Lactobacilli, NO Intervention

Other: NO Intervention

C Nugent 4 NO Lactobacilli

EXPERIMENTAL

Intermediate vaginal Flora Nugent 4 NO Lactobacilli, Intervention with vaginal probiotics, with 'Lactobacillus casei rhamnosus (Lcr 35 regenerans)

Drug: Lactobacillus casei rhamnosus (Lcr 35 regenerans)

D Nugent 4 NO Lactobacilli

ACTIVE COMPARATOR

Intermediate vaginal Flora Nugent 4 NO Lactobacilli, No Intervention

Other: NO Intervention

Interventions

Lactobacillus casei rhamnosus (Lcr 35 regenerans)DRUG

Probiotic vaginal tablets vith active probiotic strains

Also known as: Gynophilus
A Nugent 4 + LactobacilliC Nugent 4 NO Lactobacilli
NO InterventionOTHER

NO Intervention

Also known as: NO Medication
B Nugent 4 + LactobacilliD Nugent 4 NO Lactobacilli

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women 10th to 16th Week of gestation

You may not qualify if:

  • Vaginal Bleeding, Twins, vaginal infections, Antibiotics up to 4 weeks to randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (4)

  • Petricevic L, Witt A. The role of Lactobacillus casei rhamnosus Lcr35 in restoring the normal vaginal flora after antibiotic treatment of bacterial vaginosis. BJOG. 2008 Oct;115(11):1369-74. doi: 10.1111/j.1471-0528.2008.01882.x.

    PMID: 18823487BACKGROUND

  • Kiss H, Petricevic L, Husslein P. Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery. BMJ. 2004 Aug 14;329(7462):371. doi: 10.1136/bmj.38169.519653.EB. Epub 2004 Aug 4.

    PMID: 15294856BACKGROUND

  • Farr A, Kiss H, Hagmann M, Machal S, Holzer I, Kueronya V, Husslein PW, Petricevic L. Role of Lactobacillus Species in the Intermediate Vaginal Flora in Early Pregnancy: A Retrospective Cohort Study. PLoS One. 2015 Dec 11;10(12):e0144181. doi: 10.1371/journal.pone.0144181. eCollection 2015.

    PMID: 26658473RESULT

  • Petricevic L, Domig KJ, Nierscher FJ, Sandhofer MJ, Fidesser M, Krondorfer I, Husslein P, Kneifel W, Kiss H. Characterisation of the vaginal Lactobacillus microbiota associated with preterm delivery. Sci Rep. 2014 May 30;4:5136. doi: 10.1038/srep05136.

    PMID: 24875844RESULT

Study Officials

  • Ljubomir Petricevic, Prof

    Medical University Vienna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 1, 2016

Study Start

May 2, 2017

Primary Completion

November 1, 2020

Study Completion

December 30, 2020

Last Updated

February 24, 2021

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)