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Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy

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ClinicalTrials.gov Identifier: NCT03008421
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Alex Farr, MD PhD, Medical University of Vienna

Brief Summary:
In the present study, the investigators aim to evaluate the potential of oral probiotics, containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity and mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as early-onset or late-onset GBS infection.

Condition or disease Intervention/treatment Phase
Vaginal Infection Pregnancy Complications Neonatal Sepsis GBS Dietary Supplement: Astarte® (HSO Health Care GmbH, Vienna, Austria) Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy: A Randomized Placebo-controlled Double-blinded Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 1, 2020

Arm Intervention/treatment
Experimental: Study group (GBS positive w/o infection)
Treatment with study medication twice daily for 2 weeks (from study visit 1 to study visit 2)
Dietary Supplement: Astarte® (HSO Health Care GmbH, Vienna, Austria)
oral intake of Astarte® (HSO Health Care GmbH, Vienna, Austria) as described

Placebo Comparator: Placebo group (GBS positive w/o infection)
Treatment with placebo twice daily for 2 weeks (from study visit 1 to study visit 2)
Other: Placebo
Identical-looking oral potato-maltodextrin-based placebo




Primary Outcome Measures :
  1. GBS status [ Time Frame: 2 weeks ]
    Eradication of vaginal colonization with group B Streptococcus (GBS) at study visit 2


Secondary Outcome Measures :
  1. Neonatal sepsis [ Time Frame: < 7d vs. >= 7 days post partum (early vs. late-onset) ]
    Rate of early-onset and/or late-onset neonatal sepsis

  2. Gestational age at delivery [ Time Frame: 6 weeks ]
    Term delivery at or after 37 + 0 gestational weeks vs. preterm delivery at or before 36 + 6 gestational weeks

  3. Neonatal birthweight [ Time Frame: 6 weeks ]
    Birthweight of the neonate at delivery

  4. Live birth [ Time Frame: 6 weeks ]
    The rate of live birth vs. still birth at delivery

  5. Delivery mode [ Time Frame: 6 weeks ]
    The mode of delivery (vaginal vs. cesarean vs. instrumental)



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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 btw. 34 + 0 and 36 + 0 gestational weeks
  • GBS positive at GBS screening (study visit 1)
  • No current vaginal infection (i.e., Nugent score 0-6 w/o other pathogens at study visit 1)

Exclusion Criteria:

  • Multiple pregnancy
  • Vaginal bleeding
  • Current vaginal infection (i.e., bacterial vaginosis, chlamydia, trichomoniasis, candidiasis or others)
  • Antibiotics < 4 weeks to randomization
  • Probiotics < 4 weeks to randomization

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): NCT03008421


Contacts
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Contact: Alex Farr, MD PhD +43140400 ext 28220 alex.farr@meduniwien.ac.at
Contact: Ljubomir Petricevic, MD BSc +43140400 ext 28220 ljubomir.petricevic@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna, Vienna General Hospital, Department of Obstetrics and Gynecology Recruiting
Vienna, Austria, 1090
Contact: Alex Farr, MD PhD    +4314040028220    alex.farr@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Alex Farr, MD PhD, Assistant Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03008421     History of Changes
Other Study ID Numbers: MUV 022017
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Sepsis
Pregnancy Complications
Sepsis
Infection
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes