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Treatment of the Intermediate Vaginal Microbiota With Vaginal Lactobacillus Casei Rhamnosus to Improve Pregnancy Outcome (LCR35&PTD)

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ClinicalTrials.gov Identifier: NCT02979288
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Associate Prof. Ljubomir Petricevic MD, Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Lactobacillus Infection Drug: Lactobacillus casei rhamnosus (Lcr 35 regenerans) Other: NO Intervention Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Treatment of the Intermediate Vaginal Microbiota With Vaginal Probiotics Containing Lactobacillus Casei Rhamnosus (Lcr Regenerans) to Improve Pregnancy Outcomes
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A Nugent 4 + Lactobacilli
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)
Probiotic vaginal tablets vith active probiotic strains
Other Name: Gynophilus

Active Comparator: B Nugent 4 + Lactobacilli
Intermediate vaginal Flora Nugent 4 with Lactobacilli, NO Intervention
Other: NO Intervention
NO Intervention
Other Name: NO Medication

Experimental: C Nugent 4 NO Lactobacilli
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)
Probiotic vaginal tablets vith active probiotic strains
Other Name: Gynophilus

Active Comparator: D Nugent 4 NO Lactobacilli
Intermediate vaginal Flora Nugent 4 NO Lactobacilli, No Intervention
Other: NO Intervention
NO Intervention
Other Name: NO Medication




Primary Outcome Measures :
  1. the recovery to the normal vaginal microbiota (Nugent score 0 to 3). [ Time Frame: 4 Weeks ]

Secondary Outcome Measures :
  1. the gestational age at delivery, recorded as term delivery at or after 37 + 0 gestational weeks [ Time Frame: 9 Months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women 10th to 16th Week of gestation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979288


Contacts
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Contact: Ljubomir Petricevic, Prof +43140400 ext 28220 ljubomir.petricevic@meduniwien.ac.at

Locations
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Austria
Department of Obstetrics and Gynecology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Principal Investigator: Ljubomir Petricevic, Prof. M.D.         
Department of Obstetrics and Gynecology, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Peter Husslein, Prof    +4314040028210      
Principal Investigator: Ljubomir Petricevic, Prof. M.D.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Ljubomir Petricevic, Prof Medical University Vienna

Publications of Results:
Other Publications:
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Responsible Party: Associate Prof. Ljubomir Petricevic MD, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02979288    
Other Study ID Numbers: MUV 012017
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No