The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.

NCT03696953 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: R21HD095320
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks gestation and lower levels of GBS colonization, (2) less need for intrapartum antibiotic prophylaxis and (3) fewer prenatal gastrointestinal symptoms compared to women in the placebo group. Intrapartum measures were added and IRB approved in Feb 2020 as a pilot and feasibility substudy. The goals of this study are as follows: (1) Explore the effect of antepartum exposure to Florajen3 on maternal and neonatal residual GBS and the maternal microbiome. We anticipate that (1)At the time of labor, more women in the probiotics group will test negative for GBS on vaginal to rectal swabs compared to those in the placebo group and (2) Fewer neonates born to women in the probiotic group will have GBS on nasal-oral pharynx cultures within several hours of birth compared to those born to neonates in the control group.

Conditions

Group B Streptococcus Carrier in Childbirth; Gastrointestinal Symptoms

Keywords

Probiotics; Pregnancy; Group B Streptococcus; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

• Qualitative GBS Culture Result

  Qualitative GBS culture results

  36 weeks gestation

Secondary Outcomes (2)

• GBS Quantitative Colony Counts in Colony Forming Units (CFU)

  36 weeks gestation

• Antepartum Gastrointestinal Symptom Assessment

  36 weeks gestation

Other Outcomes (2)

• Intrapartum GBS Culture Result

  At the time of admission to the hospital for labor and birth (intrapartum) (Time frame will vary by participant and their health status, at or beyond 36 weeks 0/7 days gestation until 42 weeks 0/7 days gestation)

• Neonatal GBS Oral/Nasopharynx Colonization

  1-2 hours of life

Study Arms (2)

Probiotic

EXPERIMENTAL

Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth.

Biological: Florajen3

Placebo

NO INTERVENTION

Microcrystalline Cellulose

Interventions

Florajen3 BIOLOGICAL

Probiotic combination product One capsule daily by mouth.

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult (≥ 18 years of age) pregnant women who are 28±2 weeks gestation at enrollment \[calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)\]
• With: No obstetric complication\* (e.g., pre-eclampsia, gestational diabetes, multiple gestation)
• No fetal complication (e.g., birth defect, intrauterine growth restriction)
• No medical complication (e.g., hypertension, diabetes mellitus)
• Who do not currently ingest an over the counter probiotic supplement (not including yogurt)
• Who can both speak and read English
• Who regularly attend prenatal care (defined as not \> 1 prior missed appointment during this pregnancy)
• No Hypersensitivity reaction to β-lactam antibiotics

You may not qualify if:

• Those less than 18 years of age
• Non-pregnant women
• Later in pregnancy than 30 weeks gestation at enrollment \[per LNMP and/or US\]
• Those with an obstetric, fetal or medical complication of pregnancy
• Pregnant women who have a history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child
• Women who are currently ingesting an over the counter probiotic supplement (except for yogurt)
• Women who are planning an elective repeat cesarean birth
• Women who do not speak and read English
• Women with a history of missing more than one scheduled prenatal visit during this pregnancy
• Hypersensitivity reaction to β-lactam antibiotics

Sponsors & Collaborators

• Marquette University: lead
• Wake Forest University Health Sciences: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (9)

• Hanson L, Vandevusse L, Duster M, Warrack S, Safdar N. Feasibility of oral prenatal probiotics against maternal group B Streptococcus vaginal and rectal colonization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):294-304. doi: 10.1111/1552-6909.12308. Epub 2014 Apr 22.

  PMID: 24754328 BACKGROUND

• Hanson L, VandeVusse L, Jerme M, Abad CL, Safdar N. Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review. J Midwifery Womens Health. 2016 May;61(3):339-55. doi: 10.1111/jmwh.12472.

  PMID: 27218592 BACKGROUND

• VandeVusse L, Hanson L, Safdar N. Perinatal outcomes of prenatal probiotic and prebiotic administration: an integrative review. J Perinat Neonatal Nurs. 2013 Oct-Dec;27(4):288-301; quiz E1-2. doi: 10.1097/JPN.0b013e3182a1e15d.

  PMID: 24164813 BACKGROUND

• Hanson L, Vandevusse L. Probiotics are food; herbs are plants; what's the risk? Informed consent for complementary and integrative therapies. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):201-4. doi: 10.1097/JPN.0b013e3181e8f930. No abstract available.

  PMID: 20697235 BACKGROUND

• Dunn AB, Hanson L, VandeVusse L, Leslie S. Through the Microbial Looking Glass: Premature Labor, Preeclampsia, and Gestational Diabetes: A Scoping Review. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):35-51. doi: 10.1097/JPN.0000000000000375.

  PMID: 30676461 BACKGROUND

• Simonson J, Haglund K, Weber E, Fial A, Hanson L. Probiotics for the Management of Infantile Colic: A Systematic Review. MCN Am J Matern Child Nurs. 2021 Mar-Apr 01;46(2):88-96. doi: 10.1097/NMC.0000000000000691.

  PMID: 33315632 BACKGROUND

• Malloy E, Kates A, Watson L, VandeVusse L, Safdar N, Hanson L. Laboratory Analysis Techniques for the Perinatal Microbiome: Implications for Studies of Probiotic Interventions. J Perinat Neonatal Nurs. 2020 Jul/Sep;34(3):239-250. doi: 10.1097/JPN.0000000000000496.

  PMID: 32697544 BACKGROUND

• Hanson L, VandeVusse L, Forgie M, Malloy E, Singh M, Scherer M, Kleber D, Dixon J, Hryckowian AJ, Safdar N. A randomized controlled trial of an oral probiotic to reduce antepartum group B Streptococcus colonization and gastrointestinal symptoms. Am J Obstet Gynecol MFM. 2023 Jan;5(1):100748. doi: 10.1016/j.ajogmf.2022.100748. Epub 2022 Sep 13.

  PMID: 36108911 RESULT

• Hanson L, Albert K, Malloy E, Singh M, Kallay M, Brandt A, Morris C, Kleber D, Forgie M. Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics. J Midwifery Womens Health. 2025 May-Jun;70(3):452-459. doi: 10.1111/jmwh.13686. Epub 2024 Oct 1.

  PMID: 39351987 DERIVED

Results Point of Contact

• Title: Dr. Lisa Hanson
• Organization: Marquette University, College of Nursing

lisa.hanson@marquette.edu

1-414-288-3841

Study Officials

• Lisa C Hanson, PhD

  Marquette University, College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind Randomized Placebo Controlled Trial.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs Placebo) that are blind to participants and researchers. Both groups will take one capsule daily and have the same study measures at the same times.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 5, 2018
• Study Start: February 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2024
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)