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

NCT03008421 | Completed

• 1 other identifier: 1001-2017
• Study Type: interventional
• Target: 1,058
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Infection; Pregnancy Complications; Neonatal Sepsis; GBS

Outcome Measures

Primary Outcomes (1)

• GBS status

  Eradication of vaginal colonization with group B Streptococcus (GBS) at study visit 2

  2 weeks

Secondary Outcomes (5)

• Neonatal sepsis

  < 7d vs. >= 7 days post partum (early vs. late-onset)

• Gestational age at delivery

  6 weeks

• Neonatal birthweight

  6 weeks

• Live birth

  6 weeks

• Delivery mode

  6 weeks

Study Arms (2)

Study group (GBS positive w/o infection)

EXPERIMENTAL

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)

Placebo group (GBS positive w/o infection)

PLACEBO COMPARATOR

Treatment with placebo twice daily for 2 weeks (from study visit 1 to study visit 2)

Other: Placebo

Interventions

Astarte® (HSO Health Care GmbH, Vienna, Austria) DIETARY_SUPPLEMENT

oral intake of Astarte® (HSO Health Care GmbH, Vienna, Austria) as described

Study group (GBS positive w/o infection)

Placebo OTHER

Identical-looking oral potato-maltodextrin-based placebo

Placebo group (GBS positive w/o infection)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Vienna General Hospital, Department of Obstetrics and Gynecology

Vienna, 1090, Austria

Location

Related Publications (1)

• Farr A, Sustr V, Kiss H, Rosicky I, Graf A, Makristathis A, Foessleitner P, Petricevic L. Oral probiotics to reduce vaginal group B streptococcal colonization in late pregnancy. Sci Rep. 2020 Nov 12;10(1):19745. doi: 10.1038/s41598-020-76896-4.

  PMID: 33184437 DERIVED

MeSH Terms

Conditions

Vaginitis; Pregnancy Complications; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 2, 2017
• Study Start: June 1, 2018
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 8, 2020

Record last verified: 2020-02

Locations

AU (1)