{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T22:43:51Z","timestamp":1780353831617,"version":"3.54.1"},"reference-count":32,"publisher":"Walter de Gruyter GmbH","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Benef. Microbes"],"published-print":{"date-parts":[[2024,6,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n<jats:p>Group B <jats:italic>Streptococcus<\/jats:italic> (GBS) is the leading cause of bacterial neonatal sepsis. This study aimed to confirm the effect of <jats:italic>Ligilactobacillus salivarius<\/jats:italic> V4II-90 on GBS colonisation during pregnancy. A randomised, multicentre, double-blind, placebo-controlled, parallel-group study was conducted in seven hospitals in Madrid, Spain. The sample was broken down into two groups with 20 participants each (n\u00a0= 40) in order to show reduced GBS colonisation frequency in the probiotic versus the placebo group. Pregnant participants positive for vaginal-rectal colonisation before or during the 13th week of gestation were randomly assigned to either the placebo or the probiotic group. The probiotic, <jats:italic>L. salivarius<\/jats:italic> V4II-90 at 1\u00a0\u00d7 10<jats:sup>9<\/jats:sup>\u00a0cfu\/day was administered for 12 weeks, starting at week 21-23 of gestation. The primary outcome was the percentage of participants with vaginal and\/or rectal GBS colonisation at the end of the intervention period (35 weeks of gestation). Secondary outcomes were changes in the microbial composition of vaginal and rectal exudates; premature delivery; premature rupture of membranes; intrapartum antibiotics; new-borns with early or late-onset GBS sepsis; adverse events (AEs); and GBS test results performed at the hospital at week 35 of gestation. Of the 481 participants included, 44 were vaginal-rectal colonised with GBS and randomised. 43 completed the study (20 in the probiotic group and 23 in the placebo group). After intervention, GBS was eradicated in six participants (27%) from the placebo group and in twelve participants (63%) from the probiotic group (<jats:inline-formula\/>). None of the 185 AEs reported were identified as possibly, probably, or definitely related to the investigational product. In conclusion, oral administration of <jats:italic>L. salivarius<\/jats:italic> V4II-90 is a safe and successful strategy to significantly decrease the rates of GBS colonisation at the end of pregnancy and, therefore, to reduce the exposure of subjects and their infants to intrapartum antibiotic prophylaxis. Trial registered at ClinicalTrials.gov: number NCT03669094<\/jats:p>","DOI":"10.1163\/18762891-bja00021","type":"journal-article","created":{"date-parts":[[2024,7,31]],"date-time":"2024-07-31T12:50:05Z","timestamp":1722430205000},"page":"387-396","source":"Crossref","is-referenced-by-count":5,"title":["Ligilactobacillus salivarius V4II-90 eradicates Group B Streptococcus colonisation during pregnancy: a randomised, double-blind, placebo-controlled trial"],"prefix":"10.1163","volume":"15","author":[{"given":"A.","family":"Ga\u0301lvez","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, https:\/\/dx.doi.org\/207209Sanitas La Moraleja University Hospital, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"D\u0131\u0301az\u00a0de\u00a0Tera\u0301n","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, https:\/\/dx.doi.org\/207202Sanitas La Zarzuela University Hospital, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.A\u0301.","family":"Espinosa","sequence":"additional","affiliation":[{"name":"Department of Affective Childbirth, https:\/\/dx.doi.org\/221891San Francisco de As\u0131\u0301s Hospital, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1974-2242","authenticated-orcid":true,"given":"J.","family":"Pe\u0301rez-Pedregosa","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Puerta del Sur Hospital, Mo\u0301stoles, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5697-9690","authenticated-orcid":true,"given":"J.L.","family":"Bartha-Rasero","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, https:\/\/dx.doi.org\/16268La Paz University Hospital Madrid, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.G.","family":"del\u00a0Valle","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, https:\/\/dx.doi.org\/207209Sanitas La Moraleja University Hospital, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8013-4732","authenticated-orcid":true,"given":"M.J.","family":"Cuerva","sequence":"additional","affiliation":[{"name":"Department of Affective Childbirth, https:\/\/dx.doi.org\/221891San Francisco de As\u0131\u0301s Hospital, Madrid, Spain"},{"name":"Department of Obstetrics and Gynecology, https:\/\/dx.doi.org\/16268La Paz University Hospital Madrid, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7141-3588","authenticated-orcid":true,"given":"E.","family":"Jime\u0301nez","sequence":"additional","affiliation":[{"name":"Probisearch, SLU, Tres Cantos, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Badiola","sequence":"additional","affiliation":[{"name":"Casen Recordati S.L., Pozuelo de Alarco\u0301n, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","reference":[{"key":"R000001","series-title":"Clinical Infectious Diseases","first-page":"1551","article-title":"Treatment of infectious mastitis during lactation: antibiotics versus oral administration of lactobacilli isolated from breast milk","volume":"50","author":"Arroyo, R.","unstructured":"Arroyo, R., Mart\u0131\u0301n, V., Maldonado, A., Jime\u0301nez, E., Ferna\u0301ndez, L. and Rodr\u0131\u0301guez, J.M., 2010. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of lactobacilli isolated from breast milk. Clinical Infectious Diseases 50: 1551-1558. https:\/\/doi.org\/10.1086\/652763"},{"key":"R000002","series-title":"American Journal of Obstetrics and Gynecology","first-page":"S509","article-title":"Evaluation of probiotic oral supplementation effects on group b streptococcus rectovaginal colonization in pregnant women: a randomized double-blind placebo-controlled trial","volume":"218","author":"Aziz, N.","unstructured":"Aziz, N., Spiegel, A., Bentley, J., Yoffe, P., Klikoff, A., Ehrlich, K., El-Sayed, Y., Norton, M. and Taslimi, M., 2018. Evaluation of probiotic oral supplementation effects on group b streptococcus rectovaginal colonization in pregnant women: a randomized double-blind placebo-controlled trial. American Journal of Obstetrics and Gynecology 218: S509-S510. https:\/\/doi.org\/10.1016\/j.ajog.2017.11.391"},{"key":"R000003","series-title":"New Microbiologica","first-page":"307","article-title":"Dynamics of colonization with group B streptococci in relation to normal flora in women during subsequent trimesters of pregnancy","volume":"37","author":"Brzychczy-W\u0142och, M.","unstructured":"Brzychczy-W\u0142och, M., Pabian, W., Majewska, E., Zuk, M.G., Kielbik, J., Gosiewski, T. and Bulanda, M.G., 2014. Dynamics of colonization with group B streptococci in relation to normal flora in women during subsequent trimesters of pregnancy. New Microbiologica 37: 307-319."},{"key":"R000004","unstructured":"Centers for Disease Control and Prevention (CDC), nd. Active bacterial core surveillance (ABCs): bact facts interactive. 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Trends in Microbiology 26: 16-32. https:\/\/doi.org\/10.1016\/j.tim.2017.07.008"},{"key":"R000032","series-title":"International Journal of Systematic and Evolutionary Microbiology","first-page":"2782","article-title":"A taxonomic note on the genus Lactobacillus: Description of 23 novel genera, emended description of the genus Lactobacillus Beijerinck 1901 and union of Lactobacillaceae and Leuconostocaceae","volume":"70","author":"Zheng, J.","unstructured":"Zheng, J., Wittouck, S., Salvetti, E., Franz, C.M.A.P., Harris, H.M.B., Mattarelli, P., O\u2019Toole, P.W., Pot, B., Vandamme, P., Walter, J., Watanabe, K., Wuyts, S., Felis, G.E., G\u00e4nzle, M.G. and Lebeer, S., 2020. A taxonomic note on the genus Lactobacillus: Description of 23 novel genera, emended description of the genus Lactobacillus Beijerinck 1901 and union of Lactobacillaceae and Leuconostocaceae. 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