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Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02528981
First Posted: August 19, 2015
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chr Hansen
Information provided by (Responsible Party):
Mary Sharpe, Ryerson University
  Purpose

Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in Canada. It may be passed from a study participant colonized in the genital tract by GBS to their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour GBS in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per 1000 births. The use of intrapartum antibiotics to treat colonized individuals with or without risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in the past decade. Despite this impressive decline, antibiotic resistance has become a major public health concern. Association between intrapartum antibiotic use and ampicillin resistance in E. coli isolated from neonates has previously been documented. Furthermore, while GBS has remained sensitive to penicillin, 20% are resistant to erythromycin and clindamycin, which are alternate drugs for patients allergic to penicillin. Alternative approaches are therefore needed to reduce the risk of GBS infection.

We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as probiotics to treat various conditions. In particular, these two strains have shown to be beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study design involves recruiting two hundred pregnant people (one hundred in each arm) through various midwifery practices in the GTA at the end of their first trimester of pregnancy. These individuals will be randomized to receive probiotics or placebo for twelve weeks of their pregnancies and will be cultured before delivery to determine their colonization status. The capsules with probiotics and placebo will be provided free of charge. The study design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal swabs are routinely offered at 35-37 weeks of gestation.


Condition Intervention
Group B Streptococcal Infection Drug: Probiotic Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mary Sharpe, Ryerson University:

Primary Outcome Measures:
  • The GBS colonization status of people as determined by a vaginal/rectal swab [ Time Frame: After 12 weeks of taking capsules ]
    The primary outcome of this study is the GBS colonization status of people as determined by a vaginal/rectal swab, routine to the standard course of midwifery care, taken at 35-37 weeks of pregnancy. Thus, clients are asked to participate in the study for approximately 12 weeks, as per the course of probiotic/placebo. Clients will stop taking the capsules after 12 weeks and once the swab has been performed


Enrollment: 114
Study Start Date: August 2015
Study Completion Date: July 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
L. rhamnosus GR-1 and L. reuteri RC-14 will be supplied to 100 randomized pregnant people in gelatin capsules containing 2.5 billion viable cells of each strain (CFU). These organisms have been previously shown to colonize the vagina after being taken orally (11) and displace the pathogens causing bacterial vaginosis (12) and vaginal yeast infections (13), and have been shown to be an effective treatment, or accessory to treatment of these conditions. (7- 9, 13)
Drug: Probiotic
Lactobacillus GR-1 and RC-14
Placebo Comparator: Placebo
Placebo capsules will be supplied to 100 randomized pregnant people in gelatin capsules that are identical to the probiotics that the experimental group will receive.
Drug: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant prior to 23 weeks' gestation
  • Singleton pregnancy
  • Greater than 18 years of age
  • Lesser than 45 years of age
  • Signed Informed Consent
  • Consent to GBS swab that will be offered at the 35-37 week visit
  • Consent to chart review at study conclusion

Exclusion Criteria:

  • Multifetal pregnancy
  • Fetal complications
  • History of preterm birth/second trimester loss
  • Significant maternal medical complications
  • Unable to provide informed consent
  • 18 years of age or lesser than 18 years of age
  • 45 years of age or greater than 45 years of age
  • HIV positive
  • Immuno-compromised E.g.: Persons with AIDS; cancer and transplant patients who are taking certain immunosuppressive drugs; and those with inherited diseases that affect the immune system (e.g., congenital agammaglobulinemia, congenital IgA deficiency).
  • History of previous child affected by Early Onset GBS Disease (EOGBSD)
  • GBS bacteruria in pregnancy
  • Antibiotic treatment required during study period
  • Enrolled in other research with a drug
  • Taking another probiotic supplement
  Contacts and Locations
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): NCT02528981


Locations
Canada, Ontario
Ryerson University
Toronto, Ontario, Canada
Sponsors and Collaborators
Ryerson University
Chr Hansen
Investigators
Principal Investigator: Mary Sharpe, PhD Ryerson University
  More Information

Publications:
Darling E, Saurette K. Clinical Practice Guideline No.11: Group B Streptococcus: Prevention and Management in Labour. Toronto: Association of Ontario Midwives 2010.
Bocking A. Probiotic therapy for the reversal of Bacterial Vaginosis in pregnancy (ProVIP). ClinicalTrials.gov [Internet]. Accessed January 2013. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01697683?term=Bocking%2C+A&rank=10
Reid G. Effects of probiotics on rheumatoid arthritis patients. ClinicalTrials.gov [Internet]. Accessed January 2013. Available from: http://www.clinicaltrials.gov/ct2/show/NCT00664820?term=%22Canada%22+AND+%22Probiotics%22&rank=2

Responsible Party: Mary Sharpe, Associate Professor, Ryerson University
ClinicalTrials.gov Identifier: NCT02528981     History of Changes
Other Study ID Numbers: REB 2012-165
First Submitted: August 18, 2015
First Posted: August 19, 2015
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Mary Sharpe, Ryerson University:
GBS
Probiotics
Group B Streptococcal
Pregnancy

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections