Christian Gille1, Bettina Böer2, Matthias Marschal3, Michael S Urschitz4, Volker Heinecke5, Verena Hund6, Sarah Speidel1, Inge Tarnow7, Ioannis Mylonas8, Axel Franz1, Corinna Engel9, Christian F Poets10. 1. Department of Neonatology, University Children's Hospital, University Hospital, Tuebingen, Germany. 2. Department of Obstetrics and Gynecology, University Hospital, Tuebingen, Germany. 3. Institute for Medical Microbiology, University Hospital, Tuebingen, Germany. 4. Institute of Medical Biostatistics, Epidemiology, and Informatics, Division of Pediatric Epidemiology University Medical Center of the Johannes Gutenberg University Mainz, Germany. 5. Obstetric practice, Bad Urach, Germany. 6. University Pharmacy, University Hospital, Tuebingen, Germany. 7. Serendex Pharmaceuticals, Hørsholm, Denmark. 8. Department of Obstetrics and Gynecology, Ludwig-Maximilians-University, Munich, Germany. 9. Center for Pediatric Clinical Studies, University Children's Hospital, University Hospital, Tuebingen, Germany. 10. Department of Neonatology, University Children's Hospital, University Hospital, Tuebingen, Germany. Electronic address: christian-f.poets@med.uni-tuebingen.de.
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. STUDY DESIGN: We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (109 colony-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). CONCLUSION: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.
RCT Entities:
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. STUDY DESIGN: We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (109 colony-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). CONCLUSION: 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.
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