Group B Streptococcal Infection Clinical Trial
Official title:
Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial
Verified date | March 2017 |
Source | Ryerson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | July 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Ryerson University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ryerson University | Chr Hansen |
Canada,
Anukam K, Osazuwa E, Ahonkhai I, Ngwu M, Osemene G, Bruce AW, Reid G. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect. 2006 May;8(6):1450-4. — View Citation
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
Burton JP, Cadieux PA, Reid G. Improved understanding of the bacterial vaginal microbiota of women before and after probiotic instillation. Appl Environ Microbiol. 2003 Jan;69(1):97-101. — View Citation
Darling E, Saurette K. Clinical Practice Guideline No.11: Group B Streptococcus: Prevention and Management in Labour. Toronto: Association of Ontario Midwives 2010.
Kalliomäki M, Salminen S, Isolauri E. Positive interactions with the microbiota: probiotics. Adv Exp Med Biol. 2008;635:57-66. doi: 10.1007/978-0-387-09550-9_5. Review. — View Citation
Martinez RC, Franceschini SA, Patta MC, Quintana SM, Candido RC, Ferreira JC, De Martinis EC, Reid G. Improved treatment of vulvovaginal candidiasis with fluconazole plus probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. Lett Appl Microbiol. 2009 Mar;48(3):269-74. doi: 10.1111/j.1472-765X.2008.02477.x. — View Citation
Martinez RC, Franceschini SA, Patta MC, Quintana SM, Gomes BC, De Martinis EC, Reid G. Improved cure of bacterial vaginosis with single dose of tinidazole (2 g), Lactobacillus rhamnosus GR-1, and Lactobacillus reuteri RC-14: a randomized, double-blind, placebo-controlled trial. Can J Microbiol. 2009 Feb;55(2):133-8. doi: 10.1139/w08-102. — View Citation
Money DM, Dobson S; Canadian Paediatric Society, Infectious Diseases Commitee.. The prevention of early-onset neonatal group B streptococcal disease. J Obstet Gynaecol Can. 2004 Sep;26(9):826-40. Review. English, French. — View Citation
Morelli L, Zonenenschain D, Del Piano M, Cognein P. Utilization of the intestinal tract as a delivery system for urogenital probiotics. J Clin Gastroenterol. 2004 Jul;38(6 Suppl):S107-10. — View Citation
Reid G, Beuerman D, Heinemann C, Bruce AW. Probiotic Lactobacillus dose required to restore and maintain a normal vaginal flora. FEMS Immunol Med Microbiol. 2001 Dec;32(1):37-41. — View Citation
Reid G, Dols J, Miller W. Targeting the vaginal microbiota with probiotics as a means to counteract infections. Curr Opin Clin Nutr Metab Care. 2009 Nov;12(6):583-7. doi: 10.1097/MCO.0b013e328331b611. Review. — View Citation
Reid G, Kirjaivanen P. Taking probiotics during pregnancy. Are they useful therapy for mothers and newborns? Can Fam Physician. 2005 Nov;51:1477-9. Review. — View Citation
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
Stoll BJ, Hansen NI, Sánchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Erratum in: Pediatrics. 2011 Aug;128(2):390. — View Citation
Verani JR, McGee L, Schrag SJ; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC).. Prevention of perinatal group B streptococcal disease--revised guidelines from CDC, 2010. MMWR Recomm Rep. 2010 Nov 19;59(RR-10):1-36. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The GBS colonization status of people as determined by a vaginal/rectal swab | 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 | After 12 weeks of taking capsules |
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