title: Effect of probiotics on vaginal health in pregnancy. EFFPRO, a randomized controlled trial.
abstract: BACKGROUND
  Preterm delivery is a leading cause of neonatal morbidity and death. It often results from chorioamnionitis, which is a complication of bacterial vaginosis. Probiotics are effective in the treatment of bacterial vaginosis in women who were not pregnant; studies in pregnant woman are missing.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate whether an oral probiotic food supplement supports the maintenance or restoration of a normal vaginal microbiota during pregnancy.
  
  
  METHODS
  We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (109colony-forming units) or placebo were administered for 8 weeks to women with <12 completed weeks of pregnancy. Participants were enrolled at Tuebingen University Hospital and 10 recruiting gynecologic practices. Vaginal swabs were taken before and after intervention and analyzed according to the Nugent scoring system. Telephone interviews were performed before and after intervention and after delivery. Primary outcome was the proportion of swabs with normal Nugent score (<4) after intervention, compared by Fisher's exact test in an intention-to-treat analysis.
  
  
  RESULTS
  Three hundred twenty pregnant women were enrolled. Vaginal swabs were analyzed from 290 women before and 271 women after intervention. The proportion of normal vaginal microbiota decreased from 82.6 to 77.8% in the treatment group and from 79.1 to 74.3% in the placebo group, with no significant difference across groups after intervention (P=.297).
  
  
  CONCLUSIONS
  Oral probiotics may be suitable for implementation in antenatal care but, as administered here, had no effect on vaginal health during mid gestation. Other application routes or probiotic preparations may be more effective in supporting vaginal microbiota during pregnancy.
authors.affiliation: Department of Neonatology, University Children's Hospital, University Hospital, Tuebingen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Gille
authors.affiliation: Department of Obstetrics and Gynecology, University Hospital, Tuebingen, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Böer
authors.affiliation: Institute for Medical Microbiology, University Hospital, Tuebingen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Marschal
authors.affiliation: Institute of Medical Biostatistics, Epidemiology, and Informatics, Division of Pediatric Epidemiology University Medical Center of the Johannes Gutenberg University Mainz, Germany.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Urschitz
authors.affiliation: Obstetric practice, Bad Urach, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Heinecke
authors.affiliation: University Pharmacy, University Hospital, Tuebingen, Germany.
authors.forename: Verena
authors.initials: V
authors.lastname: Hund
authors.affiliation: Department of Neonatology, University Children's Hospital, University Hospital, Tuebingen, Germany.
authors.forename: Sarah
authors.initials: S
authors.lastname: Speidel
authors.affiliation: Serendex Pharmaceuticals, Hørsholm, Denmark.
authors.forename: Inge
authors.initials: I
authors.lastname: Tarnow
authors.affiliation: Department of Obstetrics and Gynecology, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Mylonas
authors.affiliation: Department of Neonatology, University Children's Hospital, University Hospital, Tuebingen, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Franz
authors.affiliation: Center for Pediatric Clinical Studies, University Children's Hospital, University Hospital, Tuebingen, Germany.
authors.forename: Corinna
authors.initials: C
authors.lastname: Engel
authors.affiliation: Department of Neonatology, University Children's Hospital, University Hospital, Tuebingen, Germany. Electronic address: christian-f.poets@med.uni-tuebingen.de.
authors.forename: Christian F
authors.initials: CF
authors.lastname: Poets
mesh_terms: D000284:Administration, Oral; D000328:Adult; D005260:Female; D006801:Humans; D052200:Limosilactobacillus reuteri; D052201:Lacticaseibacillus rhamnosus; D064307:Microbiota / Q000187:drug effects*; D008875:Middle Aged; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D019936:Probiotics / Q000494:pharmacology*; D014621:Vagina / Q000187:drug effects*; D055815:Young Adult
keywords: bacterial vaginosis; preterm birth; probiotics; vaginal microbiota