{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:45:14Z","timestamp":1792788314780,"version":"4.5.0"},"reference-count":52,"publisher":"Walter de Gruyter GmbH","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BM"],"published-print":{"date-parts":[[2023,2,23]]},"abstract":"<jats:p>\n                    The vaginal microbiota is a determinant for the risk of preterm birth (PTB). Dominance of the vaginal niche by\n                    <jats:italic>Lactobacillus crispatus<\/jats:italic>\n                    associates with term delivery. This is the first observational clinical study of live vaginal biotherapeutics (\n                    <jats:italic>Lactobacillus crispatus<\/jats:italic>\n                    CTV-05 (LACTIN-V)) in pregnant women at high-risk of PTB. The primary aim was to explore safety, tolerability and acceptability of LACTIN-V in pregnancy. Women were offered a course of LACTIN-V at 14 weeks gestation for five consecutive days followed by weekly administration for six weeks. Participants were followed up at 15, 18-, 20-, 28- and 36-weeks\u2019 gestation and at delivery for assessment of adverse events, compliance and tolerability. Participants completed a questionnaire to gauge experience and acceptability. In total, 73 women were recruited, of whom eight withdrew, leaving a final cohort size of 61. Self-reported compliance to the course was high (56\/60, 93%). Solicited adverse events were reported in 13 women (19%) including changes in vaginal discharge, odour, colour or consistency of urine, itching and vaginal bleeding. One unsolicited adverse event was reported as haematuria at 38 weeks gestation, but was judged to be unrelated to LACTIN-V. No serious adverse events occurred. One mild adverse event led to study withdrawal. Thirty-one women completed an experience and acceptability questionnaire. Women found LACTIN-V easy and comfortable to use and the majority (30\/31, 97%) would use LACTIN-V in future pregnancies. Eight women (8\/31, 26%) found the schedule of use difficult to remember. The rate of PTB &lt;34 weeks in this cohort was 3.3% compared to 7% in a historical cohort of 2,190 women at similar background PTB risk. With satisfactory uptake and good compliance, we demonstrate that LACTIN-V is safe and accepted in pregnancy, with high tolerability. Further studies are needed to assess colonisation of\n                    <jats:italic>Lactobacillus crispatus<\/jats:italic>\n                    CTV-05 and clinical efficacy.\n                  <\/jats:p>","DOI":"10.3920\/bm2022.0084","type":"journal-article","created":{"date-parts":[[2023,2,23]],"date-time":"2023-02-23T05:05:28Z","timestamp":1677128728000},"page":"45-56","source":"Crossref","is-referenced-by-count":31,"title":["Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth"],"prefix":"10.1163","volume":"14","author":[{"given":"E.","family":"Bayar","sequence":"first","affiliation":[{"name":"Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."},{"name":"March of Dimes European Prematurity Research Centre, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, UK, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.A.","family":"MacIntyre","sequence":"additional","affiliation":[{"name":"Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."},{"name":"March of Dimes European Prematurity Research Centre, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, UK, United Kingdom."},{"name":"Tommy\u2019s National Centre for Miscarriage Research. Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Sykes","sequence":"additional","affiliation":[{"name":"Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."},{"name":"March of Dimes European Prematurity Research Centre, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, UK, United Kingdom."},{"name":"The Parasol Foundation Centre for Women\u2019s Health and Cancer Research, St Mary\u2019s Hospital, Imperial College Healthcare NHS Trust, London, W2 1NY."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Mountain","sequence":"additional","affiliation":[{"name":"Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."},{"name":"March of Dimes European Prematurity Research Centre, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, UK, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.P.","family":"Parks","sequence":"additional","affiliation":[{"name":"Osel Inc., 320 Logue Ave # 114, Mountain View, CA 94043, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.P.","family":"Lee","sequence":"additional","affiliation":[{"name":"Osel Inc., 320 Logue Ave # 114, Mountain View, CA 94043, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.R.","family":"Bennett","sequence":"additional","affiliation":[{"name":"Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."},{"name":"March of Dimes European Prematurity Research Centre, Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, UK, United Kingdom."},{"name":"Tommy\u2019s National Centre for Miscarriage Research. Imperial College London, Hammersmith Hospital Campus, Du Cane Road, W120NN London, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","reference":[{"key":"atypb1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chom.2018.01.013"},{"key":"atypb2","doi-asserted-by":"publisher","DOI":"10.7717\/peerj.1398"},{"key":"atypb3","doi-asserted-by":"publisher","DOI":"10.1016\/j.jogoh.2017.11.005"},{"key":"atypb4","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD000262.pub4"},{"key":"atypb5","doi-asserted-by":"publisher","DOI":"10.1016\/j.trsl.2018.12.005"},{"key":"atypb6","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-017-0999-x"},{"key":"atypb7","doi-asserted-by":"publisher","DOI":"10.3390\/pathogens5010027"},{"key":"atypb8","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-022-28620-1"},{"key":"atypb9","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-020-15508-1"},{"key":"atypb10","doi-asserted-by":"publisher","DOI":"10.1007\/s00253-016-7531-7"},{"key":"atypb11","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1915254"},{"key":"atypb12","doi-asserted-by":"publisher","DOI":"10.1111\/jam.12947"},{"key":"atypb13","doi-asserted-by":"publisher","DOI":"10.3310\/hta24330"},{"key":"atypb14","doi-asserted-by":"publisher","DOI":"10.1155\/2007\/35387"},{"key":"atypb15","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1502875112"},{"key":"atypb16","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-019-09285-9"},{"key":"atypb17","unstructured":"Food and Drug Administration (FDA), 2016. Guidance for Industry. Early clinical trials with live biotherapeutic products: Chemistry, manufacturing, and control information. U.S. Department of Health and Human Services, FDA, Silver Spring, MD, USA. Available at: https:\/\/www.fda.gov\/media\/82945\/download"},{"key":"atypb18","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.3003605"},{"key":"atypb19","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60074-4"},{"key":"atypb20","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD012519.pub2"},{"key":"atypb21","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199512283332603"},{"key":"atypb22","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e3181a74924"},{"key":"atypb23","doi-asserted-by":"crossref","unstructured":"Hemmerling, A., Harrison, W., Schroeder, A., Park, J., Korn, A., Shiboski, S., Foster-Rosales, A. and Cohen, C.R., 2010. Phase 2a study assessing colonization efficiency, safety, and acceptability of\n                      Lactobacillus crispatus\n                      CTV-05 in women with bacterial vaginosis. Sexually Transmitted Diseases 37: 745-750. https:\/\/doi.org\/10.1097\/OLQ.0b013e3181e5","DOI":"10.1097\/OLQ.0b013e3181e50026"},{"key":"atypb24","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.15675"},{"key":"atypb25","doi-asserted-by":"publisher","DOI":"10.12669\/pjms.37.5.4187"},{"key":"atypb26","doi-asserted-by":"publisher","DOI":"10.1186\/s40168-016-0223-9"},{"key":"atypb27","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aag1026"},{"key":"atypb28","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i3633"},{"key":"atypb29","doi-asserted-by":"publisher","DOI":"10.1016\/S0029-7844(02)03054-5"},{"key":"atypb30","doi-asserted-by":"publisher","DOI":"10.1042\/ETLS20170042"},{"key":"atypb31","doi-asserted-by":"publisher","DOI":"10.1089\/jwh.2006.15.1053"},{"key":"atypb32","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijmm.2014.04.006"},{"key":"atypb33","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.1997.tb11009.x"},{"key":"atypb34","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-018021"},{"key":"atypb35","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2020.08.034"},{"key":"atypb36","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpobgyn.2020.06.002"},{"key":"atypb37","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymeth.2018.04.022"},{"key":"atypb38","doi-asserted-by":"publisher","DOI":"10.1016\/S0928-8244(02)00465-0"},{"key":"atypb39","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijmm.2015.07.005"},{"key":"atypb40","doi-asserted-by":"publisher","DOI":"10.1016\/j.imlet.2013.08.013"},{"key":"atypb41","doi-asserted-by":"publisher","DOI":"10.1007\/s00203-015-1140-1"},{"key":"atypb42","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.00101-08"},{"key":"atypb43","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cir183"},{"key":"atypb44","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2018.01.014"},{"key":"atypb45","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2011.07.010"},{"key":"atypb46","unstructured":"U.S. Department of Health and Human Services (USDHHS), 2017. Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, corrected version 2.1. USDHHS, National Institute of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS), USA. Available at: https:\/\/rsc.niaid.nih.gov\/sites\/default\/files\/daidsgradingcorrectedv21.pdf"},{"key":"atypb47","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2006.05.008"},{"key":"atypb48","first-page":"67","volume":"85","journal-title":"Ceska Gynekologie"},{"key":"atypb49","unstructured":"Wada, K., Uehara, S., Ishii, A., Sadahira, T., Yamamoto, M., Mitsuhata, R., Takamoto, A., Araki, M., Kobayashi, Y. and Watanabe, M., 2016. A Phase II clinical trial evaluating the preventive effectiveness of\n                      lactobacillus\n                      vaginal suppositories in patients with recurrent cystitis. Acta Medica Okayama 70: 299-302. https:\/\/doi.org\/10.18926\/AMO\/54508"},{"key":"atypb50","doi-asserted-by":"crossref","first-page":"1020","DOI":"10.1111\/1471-0528.16566","volume":"128","journal-title":"BJOG"},{"key":"atypb51","doi-asserted-by":"publisher","DOI":"10.3390\/nu12020368"},{"key":"atypb52","doi-asserted-by":"publisher","DOI":"10.3390\/nu12041141"}],"container-title":["Beneficial Microbes"],"original-title":[],"link":[{"URL":"https:\/\/brill.com\/view\/journals\/bm\/14\/1\/article-p45_4.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/brill.com\/downloadpdf\/journals\/bm\/14\/1\/article-p45_4.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/brill.com\/downloadpdf\/journals\/bm\/14\/1\/article-p45_4.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T05:26:57Z","timestamp":1713245217000},"score":1,"resource":{"primary":{"URL":"https:\/\/brill.com\/view\/journals\/bm\/14\/1\/article-p45_4.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,23]]},"references-count":52,"journal-issue":{"issue":"1"},"URL":"https:\/\/doi.org\/10.3920\/bm2022.0084","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-1418870\/v1","asserted-by":"object"}]},"ISSN":["1876-2883","1876-2891"],"issn-type":[{"value":"1876-2883","type":"print"},{"value":"1876-2891","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,23]]}}}