Effectiveness of oral intake of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 on Group B Streptococcus colonization during pregnancy: a midwifery-led double-blind randomized controlled pilot trial.

2019-08-13
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 34(11)

PubMed: 31362572
DOI: 10.1080/14767058.2019.1650907

Study Design

Type: Randomized Controlled Trial (RCT)
Population: Pregnant midwifery clients >18 years of age and <45 years of age and with a gestational age of <25 weeks at the time of enrolment
Methods: Randomly assigned to receive two capsules of probiotics (Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) or placebo orally daily for 12 weeks at 23-25 weeks' gestation

Objective

Group B streptococcus (GBS) vaginal/rectal colonization in pregnancy has been associated with early-onset GBS disease (EOGBSD), a leading cause of neonatal morbidity and mortality. In Canada, universal screening for GBS colonization is offered to pregnant people at 35-37 weeks' gestation and those who test positive are offered intrapartum antibiotic prophylaxis (IAP). Universal screening and treatment with IAP have not eradicated all cases of EOGBSD, and IAP has documented side effects. Probiotic supplements have been proposed as a possible way to reduce GBS colonization.

Materials and methods

Pregnant midwifery clients >18 years of age and <45 years of age and with a gestational age of <25 weeks at the time of enrolment were randomly assigned to receive two capsules of probiotics (Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) or placebo orally daily for 12 weeks at 23-25 weeks' gestation. The primary aim was to determine the feasibility of a larger study. The rate of GBS vaginal/rectal colonization at 35-37 weeks' gestation was also assessed in both groups.

Results

In total, 139 pregnant midwifery clients were randomized (probiotic group [N = 73] and placebo group [N = 66]). Of these, 113 were included in the final analysis (probiotic group [N = 57] and placebo group [N = 56]). Baseline characteristics between groups were similar with the exception of gestational age (p < .01). The recruitment rate was low at 12%, but the mean compliance rate was 87%. The eligibility/ineligibility criteria were too strict and changes to the study design will be required for the larger proposed study. The rates of vaginal/rectal GBS colonization did not differ significantly between groups (15.8 versus 21.43%; p = .48). No adverse effects were documented in the probiotic group.

Conclusion

This was the first midwifery-led trial involving a natural health product in the province of Ontario. Although treatment with oral probiotics is feasible, the results were not superior to placebo in reducing the rate of GBS colonization. An adequately powered, randomly controlled trial is required to assess the effectiveness of the two probiotic strains.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Lactobacillus reuteri RC-14	—	No Documented Adverse Effects	Beneficial	Small	View source No adverse effects were documented in the probiotic group.
Lactobacillus reuteri RC-14	—	Reduced Vaginal Group B Streptococcus Colonization	Neutral	Small	View source The rates of vaginal/rectal GBS colonization did not differ significantly between groups (15.8 versus 21.43%; p = .48).