1. Effects of oral probiotic supplements on vaginal microbiota during pregnancy: a randomised, double‐blind, placebo‐controlled trial with microbiome analysis
- Author
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Javier Zamora, Khalid S. Khan, Borja M. Fernandez-Felix, Christine McCourt, Julie Dodds, Zoe Drymoussi, Shahid Husain, John Allotey, Erica M Prosdocimi, B M de Tejada, Shakila Thangaratinam, Angela Whiley, Michael Millar, Mark Wilks, and William G. Wade
- Subjects
education.field_of_study ,medicine.medical_specialty ,Pregnancy ,business.industry ,Population ,Placebo-controlled study ,Obstetrics and Gynecology ,Placebo ,medicine.disease ,law.invention ,Probiotic ,law ,Internal medicine ,medicine ,Gestation ,Nugent score ,RG ,Bacterial vaginosis ,education ,business - Abstract
OBJECTIVE: To determine the effects on the vaginal microbiota of an oral probiotic preparation administered from early pregnancy. \ud \ud DESIGN: Randomised, double blind, placebo-controlled trial. \ud \ud SETTING: Four maternity units in the UK. \ud \ud POPULATION: Women aged 16 years or older recruited at 9-14 weeks' gestation. \ud \ud METHODS: Participants were randomly allocated to receive oral capsules of probiotic containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each at 2.5 × 109 colony-forming units (CFUs) or placebo once daily from recruitment until the end of pregnancy. \ud \ud MAIN OUTCOME MEASURE: Rates of bacterial vaginosis (BV, defined as Nugent score ≥7) at 18-20 weeks' gestation compared by logistic regression adjusted for possible confounders. \ud \ud RESULTS: The primary analysis included 78% (238/304) of participants who initially consented (probiotic group 123, placebo group 115). Of these participants, 95% (227/238) reported an intake of 93% or more of the required number of capsules. The rates of BV did not differ between groups at 18-20 weeks' gestation (15% (19/123) in the probiotic group vs. 9% (10/115) in the placebo group, adjusted odds ratio 1.82, 95% confidence interval 0.64-5.19). There were also no differences between the groups in the proportion of women colonised with the probiotic strains, Escherichia coli, Group B streptococci or other vaginal microbiota. There were no differences in the alpha diversity or composition of the bacterial communities between or within the probiotic and placebo groups at 9-14 and 18-20 weeks' gestation. \ud \ud CONCLUSIONS: Oral probiotics taken from early pregnancy did not modify the vaginal microbiota. \ud \ud TWEETABLE ABSTRACT: The oral probiotic preparation used in this study does not prevent BV in pregnant women.
- Published
- 2019
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