{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T05:03:08Z","timestamp":1789016588922,"version":"build-2803163510"},"reference-count":50,"publisher":"Walter de Gruyter GmbH","issue":"3","license":[{"start":{"date-parts":[[2022,8,3]],"date-time":"2022-08-03T00:00:00Z","timestamp":1659484800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BM"],"published-print":{"date-parts":[[2022,8,3]]},"abstract":"<jats:p>The administration of probiotics may help to improve dysbiosis and related health problems in children delivered by caesarean section. However, the effects are strain specific, and safety combined tolerance are considered a priority. The aim of this study was to evaluate the safety and tolerance of <jats:italic>Lacticaseibacillus paracasei<\/jats:italic> N1115 in caesarean-born children aged 6-24 months via a randomised, placebo-controlled intervention study. In total, 101 children were included and randomised to receive either a sachet of <jats:italic>L. paracasei<\/jats:italic> N1115 (2\u00d710<jats:sup>10<\/jats:sup> cfu\/g, 2 g\/day) or placebo (maltodextrin, 2 g\/day) per day for 12 weeks. Anthropometric parameters were measured by trained nurses, and defecation characteristics, gastrointestinal symptoms, (serious) adverse events ((s)AEs), crying patterns and lifestyle behaviours were recorded by parents or guardians. Neurocognitive development was assessed by the Ages and Stages Questionnaires-3 (ASQ-3) before and after the intervention. The only difference between groups regarding defecation characteristics was a significant treatment \u00d7 time effect on stool frequency (<jats:italic>P<\/jats:italic>=0.007), as the number of defecations was significantly higher in the probiotic group (around 1.2-1.3 times\/day) than in the placebo group (around 1.0 times\/day) in the later intervention period (<jats:italic>P<\/jats:italic>=0.035 at week 9; <jats:italic>P<\/jats:italic>=0.048 at week 10; <jats:italic>P<\/jats:italic>=0.026 at week 12). The use of <jats:italic>L. paracasei<\/jats:italic> N1115 also reduced the incidence rate of constipation (Incidence rate ratio (IRR): 0.120; 95% confidence interval (CI): 0.015, 0.967; <jats:italic>P<\/jats:italic>=0.046) and abdominal pain (IRR: 0.562; 95% CI: 0.358, 0.882; <jats:italic>P<\/jats:italic>=0.012). Changes in anthropometric parameters, including weight, height and head circumference, did not differ significantly between groups, nor did measures of crying, sleep, outdoor activity, temper, appetite or the ASQ-3 scores. No adverse events associated with consumption of the probiotic were reported. Thus, the administration of <jats:italic>L. paracasei<\/jats:italic> N1115 is safe and well-tolerated in caesarean-born children aged 6-24 months. Furthermore, it may ameliorate gastrointestinal function to some extent.<\/jats:p>","DOI":"10.3920\/bm2021.0132","type":"journal-article","created":{"date-parts":[[2022,3,18]],"date-time":"2022-03-18T08:58:07Z","timestamp":1647593887000},"page":"205-220","source":"Crossref","is-referenced-by-count":7,"title":["Safety and tolerance of Lacticaseibacillus paracasei N1115 in caesarean-born young children: a randomised, placebo-controlled trial"],"prefix":"10.1163","volume":"13","author":[{"given":"Z.","family":"Ren","sequence":"first","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Zhao","sequence":"additional","affiliation":[{"name":"Vanke School of Public Health, Tsinghua University, Beijing 100091, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Zhong","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Mao","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Wang","sequence":"additional","affiliation":[{"name":"Shijiazhuang Junlebao Dairy Co. Ltd., Shijiazhuang 050221, China P.R."},{"name":"Peking University Medical Science-Junlebao Dairy Joint Laboratory of Breast Milk Science and Life Health, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Q.","family":"Yuan","sequence":"additional","affiliation":[{"name":"Shijiazhuang Junlebao Dairy Co. Ltd., Shijiazhuang 050221, China P.R."},{"name":"Peking University Medical Science-Junlebao Dairy Joint Laboratory of Breast Milk Science and Life Health, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Social Medicine and Health Education, School of Public Health, Peking University, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China P.R."},{"name":"Peking University Medical Science-Junlebao Dairy Joint Laboratory of Breast Milk Science and Life Health, Beijing 100191, China P.R."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","reference":[{"key":"atypb1","doi-asserted-by":"publisher","DOI":"10.1177\/0148607115588113"},{"key":"atypb2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.06.062"},{"key":"atypb3","doi-asserted-by":"publisher","DOI":"10.5812\/ijp.9322"},{"key":"atypb4","doi-asserted-by":"publisher","DOI":"10.3390\/nu10020195"},{"key":"atypb5","doi-asserted-by":"publisher","DOI":"10.3390\/nu10111693"},{"key":"atypb6","doi-asserted-by":"publisher","DOI":"10.24953\/turkjped.2021.03.013"},{"key":"atypb7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31928-7"},{"key":"atypb8","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e3181fb9e80"},{"key":"atypb9","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-019-02807-x"},{"key":"atypb10","unstructured":"Cao, Y., Zhang, J., Zheng, Z., Mei, X., Wang, S., Zhu, H. and Yang, N., 2018. Therapeutic Effect of Lactobacillus paracasei N1115 fermented milk in constipated mice. Food Science 39: 185-191. https:\/\/doi.org\/10.7506\/spkx1002-6630-201801028"},{"key":"atypb11","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2010.04.066"},{"key":"atypb12","doi-asserted-by":"publisher","DOI":"10.3389\/fmolb.2021.688440"},{"key":"atypb13","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-016225"},{"key":"atypb14","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00018.2018"},{"key":"atypb15","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-020-06092-x"},{"key":"atypb16","doi-asserted-by":"publisher","DOI":"10.3945\/an.116.014407"},{"key":"atypb17","unstructured":"Food and Agriculture Organization of the United Nations\/World Health Organization (FAO\/WHO), 2002. Guidelines for the evaluation of probiotics in food. Report of a Joint FAO\/WHO working group on drafting guidelines for the evaluation of probiotics in food. Available at: http:\/\/tinyurl.com\/zdbrkeg."},{"key":"atypb18","unstructured":"Feng, L., Wang, H., Wang, S., Li, X. and Zhu, H., 2017. The study of the improvement of intestinal health by instant type Lactobacillus power. Food Research and Development 38: 34-37. https:\/\/doi.org\/10.3969\/j.issn.1005-6521.2017.09.008"},{"key":"atypb19","doi-asserted-by":"publisher","DOI":"10.1159\/000490847"},{"key":"atypb20","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2012.05180.x"},{"key":"atypb21","doi-asserted-by":"publisher","DOI":"10.3390\/nu10121975"},{"key":"atypb22","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2011.11.016"},{"key":"atypb23","doi-asserted-by":"publisher","DOI":"10.1002\/jpen.1468"},{"key":"atypb24","doi-asserted-by":"publisher","DOI":"10.1039\/C5FO01148E"},{"key":"atypb25","doi-asserted-by":"publisher","DOI":"10.1111\/apa.15501"},{"key":"atypb26","doi-asserted-by":"publisher","DOI":"10.1007\/s12098-017-2447-5"},{"key":"atypb27","doi-asserted-by":"publisher","DOI":"10.1007\/s12602-021-09800-9"},{"key":"atypb28","doi-asserted-by":"publisher","DOI":"10.3389\/fnut.2021.587974"},{"key":"atypb29","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2016.06.055"},{"key":"atypb30","doi-asserted-by":"publisher","DOI":"10.1016\/j.mib.2018.06.003"},{"key":"atypb31","doi-asserted-by":"publisher","DOI":"10.1152\/ajpgi.00107.2019"},{"key":"atypb32","doi-asserted-by":"publisher","DOI":"10.3390\/nu12020363"},{"key":"atypb33","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2018.00124"},{"key":"atypb34","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003429"},{"key":"atypb35","doi-asserted-by":"publisher","DOI":"10.1093\/nutrit\/nuw069"},{"key":"atypb36","doi-asserted-by":"publisher","DOI":"10.1186\/1475-2891-11-81"},{"key":"atypb37","doi-asserted-by":"publisher","DOI":"10.33073\/pjm-2021-002"},{"key":"atypb38","doi-asserted-by":"publisher","DOI":"10.2147\/CIA.S141518"},{"key":"atypb39","doi-asserted-by":"publisher","DOI":"10.5056\/jnm.2011.17.2.140"},{"key":"atypb40","doi-asserted-by":"publisher","DOI":"10.3920\/BM2018.0013"},{"key":"atypb41","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2020.583946"},{"key":"atypb42","unstructured":"ASQ-3 user\u2019s guide"},{"key":"atypb43","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2431-13-185"},{"key":"atypb44","doi-asserted-by":"publisher","DOI":"10.1002\/fsn3.2533"},{"key":"atypb45","unstructured":"Wang, S., Yan, F., He, F. and Zhu, H., 2016. Effects of Lactobacillus paracasei N1115 on intestinal development in neonatal mice. Acta Nutrimenta Sinica 38: 71-74. https:\/\/doi.org\/10.13325\/j.cnki.acta.nutr.sin.2016.01.015"},{"key":"atypb46","doi-asserted-by":"publisher","DOI":"10.1128\/genomeA.00059-14"},{"key":"atypb47","unstructured":"Xun, Y., Zhu, H., Feng, L., Zhang, D., Xue, Y. and Wang, S., 2020. Effects of Lactobacillus paracasei N1115 on intestinal health in infants born by caesarean section. Acta Nutrimenta Sinica 42: 338-343. https:\/\/doi.org\/10.3969\/j.issn.0512-7955.2020.04.006"},{"key":"atypb48","doi-asserted-by":"publisher","DOI":"10.5114\/aoms.2019.86611"},{"key":"atypb49","doi-asserted-by":"publisher","DOI":"10.5223\/pghn.2017.20.1.1"},{"key":"atypb50","doi-asserted-by":"publisher","DOI":"10.12938\/bmfh.2019-025"}],"container-title":["Beneficial Microbes"],"original-title":[],"link":[{"URL":"https:\/\/brill.com\/view\/journals\/bm\/13\/3\/article-p205_4.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/brill.com\/downloadpdf\/journals\/bm\/13\/3\/article-p205_4.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/brill.com\/downloadpdf\/journals\/bm\/13\/3\/article-p205_4.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T09:29:31Z","timestamp":1713259771000},"score":1,"resource":{"primary":{"URL":"https:\/\/brill.com\/view\/journals\/bm\/13\/3\/article-p205_4.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,3]]},"references-count":50,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.3920\/bm2021.0132","relation":{},"ISSN":["1876-2883","1876-2891"],"issn-type":[{"value":"1876-2883","type":"print"},{"value":"1876-2891","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,3]]}}}