Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- The primary outcome will be vaginal/rectal GBS colonization status at delivery
研究概览
简要总结
This is a double-blind randomized placebo controlled trial that will investigate whether the use of three specific species of probiotics taken orally in pregnancy from 25 weeks gestation will reduce the incidence of Group B Streptococcus (GBS) colonization. Participants will take 2 capsules and 1 lozenge per day of either probiotic or placebo from 25 weeks gestation. The primary outcome will be the study-specific vaginal/rectal swab collected after 35 weeks gestation and before delivery. A reduction in women testing positive for GBS would lead to a decrease risk to infants of GBS infection and a reduction in the use of antibiotics leading to less maternal and neonatal antibiotic exposure.
详细描述
Background:
Group B streptococcus (GBS) infection of the newborn is a leading cause of neonatal morbidity and mortality in North America. Up to 30% of pregnant women are colonized with GBS. Half of the babies born to colonized mothers will become colonized themselves, and of those, about 1-2% may develop early onset GBS infection (EOGBS), which is associated with significant mortality (between 5% and 20%) and morbidity (71% bacteremia, 11% meningitis, 19% pneumonia). The current recommendation is for routine administration of IPA to women who test positive for GBS at term. Although IPA therapy may reduce the incidence of neonatal GBS infection, it can increase the risk of other infections such as E. Coli, neonatal thrush, and ampicillin resistant Enterobacteriaceae.
There is also accumulating evidence linking antibiotics in pregnancy with childhood asthma, childhood obesity, and obesity in later life. IPA is also associated with antibiotic resistance, diarrhoea (including Clostridium difficile), and fungal infections. There is a growing worldwide interest in utilizing probiotics to enhance and manipulate the human microbiome in order to reduce a wide range of communicable and non-communicable diseases. Probiotics have been studied extensively in pregnant women and are considered safe and well tolerated when ingested or used vaginally.
Probiotics in pregnancy may reduce GBS colonization and the need for intrapartum antibiotic prophylaxis through a number of mechanisms. Some probiotics produce antibacterial substances and film-like barriers to pathogens. By adhering to vaginal epithelial cells, probiotics also displace pathogens such as GBS. S. salivarius K12 has been shown to inhibit several GBS strains, including disease-implicated isolates from newborns and colonizing isolates from the vaginal tract of pregnant women. In vivo and in vitro studies demonstrate its ability to adhere to the vaginal epithelium and directly impair the growth and adherence of GBS.
Several pilot randomized trials of L. reuteri and L. rhamnosus show promise in their their ability to reduce GBS colonization and have been shown to be safe. In vivo and in vitro studies of various lactobacillus strains, including rhamnosus and reuteri, have demonstrated an inhibitory effect on GBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomisation process will assign each participant with a unique study ID number. This study ID number will be required when allocating study drug bottles and lozenge packages and for recording data on the case report form (CRF). The drug bottle number and lozenge packs will be dispensed by a study team member directly to the participant. Probiotics and placebos will look and taste identical and drug bottles and lozenge packs and labels will look identical.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant with a singleton
- •Gestational age between 23 and 25+0 weeks
- •Over the age of 18
- •Registered for delivery, at one of the participating centres
- •Under the care of a regulated maternity care provider (midwife, obstetrician (OB), or family physician).
排除标准
- •Unable to provide consent
- •Fetus has known major anomalies
- •Significant immunosuppression
- •Type I or Type II diabetes (non-gestational)
- •Previous infant with GBS (these women will automatically be advised to be treated with IV antibiotic therapy)
- •GBS bacteriuria diagnosed in present pregnancy (reasoning as per above)
- •Plans to use oral or vaginal probiotic supplementation/therapy (capsules/tablets/lozenges/drinks) during their pregnancy (outside of natural food sources; yogurt, kimchi, kombucha etc)
- •Enrolled in another study that involves the administration of a drug/product
结局指标
主要结局
The primary outcome will be vaginal/rectal GBS colonization status at delivery
时间窗: Last vaginal/rectal swab taken after 35 weeks gestation and prior to delivery
Measured using the study-specific rectal/vaginal swab
次要结局
- Maternal urinary tract infections(Questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (6 weeks post-birth))
- Maternal vaginal candida infections(Questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (4-6 weeks postpartum))
- Maternal antibiotic exposure(Questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (6 weeks post-birth))
- Maternal bacterial vaginosis infections(Questionnaires administered at intake (22-25 weeks), mid-term (29-33 weeks), term (35-37 weeks) and chart review (6 weeks post-birth))
研究者
Michelle Butler
Principal Investigator
University of British Columbia