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 Lacticaseibacillus paracasei 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 L. paracasei N1115 (2Ã1010 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 à time effect on stool frequency (P=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 (P=0.035 at week 9; P=0.048 at week 10; P=0.026 at week 12). The use of L. paracasei N1115 also reduced the incidence rate of constipation (Incidence rate ratio (IRR): 0.120; 95% confidence interval (CI): 0.015, 0.967; P=0.046) and abdominal pain (IRR: 0.562; 95% CI: 0.358, 0.882; P=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 L. paracasei N1115 is safe and well-tolerated in caesarean-born children aged 6-24 months. Furthermore, it may ameliorate gastrointestinal function to some extent.
Athalye-Jape, G., Rao, S. and Patole, S., 2016. Lactobacillus reuteri DSM 17938 as a probiotic for preterm neonates: a strain-specific systematic review. Journal of Parenteral and Enteral Nutrition 40: 783-794. https://doi.org/10.1177/0148607115588113
Azpiroz, F. and Malagelada, J.R., 2005. Abdominal bloating. Gastroenterology 129: 1060-1078. https://doi.org/10.1053/j.gastro.2005.06.062
Baldassarre, M.E., Di Mauro, A., Cintoli, A., Mincarone, G., S., T. and Laforgia, N., 2017. Non-communicable chronic diseases: the role of neonatal characteristics. Iranian Journal of Pediatrics 27: e9322. https://doi.org/10.5812/ijp.9322
Baldassarre, M.E., Di Mauro, A., Tafuri, S., Rizzo, V., Gallone, M.S., Mastromarino, P., Capobianco, D., Laghi, L., Zhu, C., Capozza, M. and Laforgia, N., 2018a. Effectiveness and safety of a probiotic-mixture for the treatment of infantile colic: a double-blind, randomized, placebo-controlled clinical trial with fecal real-time PCR and NMR-based metabolomics analysis. Nutrients 10: 195. https://doi.org/10.3390/nu10020195
Baldassarre, M.E., Palladino, V., Amoruso, A., Pindinelli, S., Mastromarino, P., Fanelli, M., Di Mauro, A. and Laforgia, N., 2018b. Rationale of probiotic supplementation during pregnancy and neonatal period. Nutrients 10: 1693. https://doi.org/10.3390/nu10111693
Bekem, Ã., Günay, İ., Ãelik, F. and Apa, H., 2021. Interaction of functional gastrointestinal disorders with postpartum conditions related to mother and baby. Turkish Journal of Pediatrics 63: 461-470. https://doi.org/10.24953/turkjped.2021.03.013
Boerma, T., Ronsmans, C., Melesse, D.Y., Barros, A.J.D., Barros, F.C., Juan, L., Moller, A.B., Say, L., Hosseinpoor, A.R., Yi, M., de Lyra Rabello Neto, D. and Temmerman, M., 2018. Global epidemiology of use of and disparities in caesarean sections. The Lancet 392: 1341-1348. https://doi.org/10.1016/s0140-6736(18)31928-7
Braegger, C., Chmielewska, A., Decsi, T., Kolacek, S., Mihatsch, W., Moreno, L., Piescik, M., Puntis, J., Shamir, R., Szajewska, H., Turck, D. and van Goudoever, J., 2011. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. Journal of Pediatric Gastroenterology and Nutrition 52: 238-250. https://doi.org/10.1097/MPG.0b013e3181fb9e80
Callaway, E., 2019. C-section babies are missing key microbes. Nature, 18 September 2019. https://doi.org/10.1038/d41586-019-02807-x
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
Coccorullo, P., Strisciuglio, C., Martinelli, M., Miele, E., Greco, L. and Staiano, A., 2010. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. Journal of Pediatrics 157: 598-602. https://doi.org/10.1016/j.jpeds.2010.04.066
Conta, G., Del Chierico, F., Reddel, S., Marini, F., Sciubba, F., Capuani, G., Tomassini, A., Di Cocco, M.E., Laforgia, N., Baldassarre, M.E., Putignani, L. and Miccheli, A., 2021. Longitudinal multi-omics study of a mother-infant dyad from breastfeeding to weaning: an individualized approach to understand the interactions among diet, fecal metabolome and microbiota composition. Frontiers in Molecular Bioscience 8: 688440. https://doi.org/10.3389/fmolb.2021.688440
Crellin, D.J., Harrison, D., Hutchinson, A., Schuster, T., Santamaria, N. and Babl, F.E., 2017. Procedural Pain Scale Evaluation (PROPoSE) study: protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6-42 months. BMJ Open 7: e016225. https://doi.org/10.1136/bmjopen-2017-016225
Cryan, J.F., OâRiordan, K.J., Cowan, C.S.M., Sandhu, K.V., Bastiaanssen, T.F.S., Boehme, M., Codagnone, M.G., Cussotto, S., Fulling, C., Golubeva, A.V., Guzzetta, K.E., Jaggar, M., Long-Smith, C.M., Lyte, J. M., Martin, J.A., Molinero-Perez, A., Moloney, G., Morelli, E., Morillas, E., OâConnor, R., Cruz-Pereira, J.S., Peterson, V.L., Rea, K., Ritz, N.L., Sherwin, E., Spichak, S., Teichman, E.M., van de Wouw, M., Ventura-Silva, A.P., Wallace-Fitzsimons, S.E., Hyland, N., Clarke, G. and Dinan, T.G., 2019. The microbiota-gut-brain axis. Physiological Reviews 99: 1877-2013. https://doi.org/10.1152/physrev.00018.2018
Davis, E.C., Dinsmoor, A.M., Wang, M. and Donovan, S.M., 2020. Microbiome composition in pediatric populations from birth to adolescence: impact of diet and prebiotic and probiotic interventions. Digestive Diseases and Sciences 65: 706-722. https://doi.org/10.1007/s10620-020-06092-x
Dimidi, E., Christodoulides, S., Scott, S.M. and Whelan, K., 2017. Mechanisms of action of probiotics and the gastrointestinal microbiota on gut motility and constipation. Advances in Nutrition 8: 484-494. https://doi.org/10.3945/an.116.014407
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.
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
Francavilla, R., Cristofori, F., Tripaldi, M.E. and Indrio, F., 2018. Intervention for dysbiosis in children born by c-section. Annals of Nutrition and Metabolism 73 Suppl. 3: 33-39. https://doi.org/10.1159/000490847
Francavilla, R., Lionetti, E., Castellaneta, S., Ciruzzi, F., Indrio, F., Masciale, A., Fontana, C., La Rosa, M.M., Cavallo, L. and Francavilla, A., 2012. Randomised clinical trial: Lactobacillus reuteri DSM 17938 vs. placebo in children with acute diarrhoea--a double-blind study. Alimentary Pharmacology and Therapeutics 36: 363-369. https://doi.org/10.1111/j.1365-2036.2012.05180.x
Gerasimov, S., Gantzel, J., Dementieva, N., Schevchenko, O., Tsitsura, O., Guta, N., Bobyk, V. and Kaprus, V., 2018. Role of Lactobacillus rhamnosus (FloraActiveâ¢) 19070-2 and Lactobacillus reuteri (FloraActiveâ¢) 12246 in infant colic: a randomized dietary study. Nutrients 10: 1975. https://doi.org/10.3390/nu10121975
Gil-Campos, M., López, M., Rodriguez-BenÃtez, M.V., Romero, J., Roncero, I., Linares, M.D., Maldonado, J., López-Huertas, E., Berwind, R., Ritzenthaler, K.L., Navas, V., Sierra, C., Sempere, L., Geerlings, A., Maldonado-Lobón, J.A., Valero, A.D., Lara-Villoslada, F. and Olivares, M., 2012. Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1-6 months of age: a randomized controlled trial. Pharmacological Research 65: 231-238. https://doi.org/10.1016/j.phrs.2011.11.016
Gustin, J., Gibb, R., Kenneally, D., Kutay, B., Waimin Siu, S. and Roe, D., 2018. Characterizing exclusively breastfed infant stool via a novel infant stool scale. Journal of Parenteral and Enteral Nutrition 42 Suppl. 1: S5-S11. https://doi.org/10.1002/jpen.1468
Hashemi, A., Villa, C.R. and Comelli, E.M., 2016. Probiotics in early life: a preventative and treatment approach. Food and Function 7: 1752-1768. https://doi.org/10.1039/c5fo01148e
Hoang, D.M., Levy, E.I. and Vandenplas, Y., 2021. The impact of caesarean section on the infant gut microbiome. Acta Paediatrica 110: 60-67. https://doi.org/10.1111/apa.15501
Iyer, R. and Nallasamy, K., 2018. Child with abdominal pain. Indian Journal of Pediatrics 85: 71-76. https://doi.org/10.1007/s12098-017-2447-5
Kong, X.J., Liu, K., Zhuang, P., Tian, R., Liu, S., Clairmont, C., Lin, X., Sherman, H., Zhu, J., Wang, Y., Fong, M., Li, A., Wang, B.K., Wang, J., Yu, Z., Shen, C., Cui, X., Cao, H., Du, T., Wan, G. and Cao, X., 2021a. The effects of Limosilactobacillus reuteri LR-99 supplementation on body mass index, social communication, fine motor function, and gut microbiome composition in individuals with Prader-Willi syndrome: a randomized double-blinded placebo-controlled trial. Probiotics and Antimicrobial Proteins 13: 1508-1520. https://doi.org/10.1007/s12602-021-09800-9
Kong, X.J., Wan, G., Tian, R., Liu, S., Liu, K., Clairmont, C., Lin, X., Zhang, X., Sherman, H., Zhu, J., Wang, Y., Fong, M., Li, A., Wang, B.K., Wang, J., Liu, J., Yu, Z., Shen, C., Cui, X., Cao, H., Du, T. and Cao, X., 2021b. The effects of probiotic supplementation on anthropometric growth and gut microbiota composition in patients with Prader-Willi syndrome: a randomized double-blinded placebo-controlled trial. Frontiers in Nutrition 8: 587974. https://doi.org/10.3389/fnut.2021.587974
Koppen, I.J.N., Velasco-Benitez, C.A., Benninga, M.A., Di Lorenzo, C. and Saps, M., 2016. Using the Bristol stool scale and parental report of stool consistency as Part of the Rome III criteria for functional constipation in infants and toddlers. Journal of Pediatrics 177: 44-48.e41. https://doi.org/10.1016/j.jpeds.2016.06.055
Korpela, K. and de Vos, W.M., 2018. Early life colonization of the human gut: microbes matter everywhere. Current Opinion in Microbiology 44: 70-78. https://doi.org/10.1016/j.mib.2018.06.003
Liu, Y., Tian, X., He, B., Hoang, T.K., Taylor, C.M., Blanchard, E., Freeborn, J., Park, S., Luo, M., Couturier, J., Tran, D.Q., Roos, S., Wu, G. and Rhoads, J.M., 2019. Lactobacillus reuteri DSM 17938 feeding of healthy newborn mice regulates immune responses while modulating gut microbiota and boosting beneficial metabolites. American Journal of Physiology â Gastrointestinal and Liver Physiology 317: G824-g838. https://doi.org/10.1152/ajpgi.00107.2019
Martoni, C.J., Srivastava, S. and Leyer, G.J., 2020. Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 improve abdominal pain severity and symptomology in irritable bowel syndrome: randomized controlled trial. Nutrients 12: 363. https://doi.org/10.3390/nu12020363
McFarland, L.V., Evans, C.T. and Goldstein, E.J.C., 2018. Strain-specificity and disease-specificity of probiotic efficacy: a systematic review and meta-analysis. Frontiers in Medicine 5: 124. https://doi.org/10.3389/fmed.2018.00124
Miller, J.E., Goldacre, R., Moore, H.C., Zeltzer, J., Knight, M., Morris, C., Nowell, S., Wood, R., Carter, K.W., Fathima, P., de Klerk, N., Strunk, T., Li, J., Nassar, N., Pedersen, L.H. and Burgner, D.P., 2020. Mode of birth and risk of infection-related hospitalisation in childhood: A population cohort study of 7.17 million births from 4 high-income countries. PLoS Medicine 17: e1003429. https://doi.org/10.1371/journal.pmed.1003429
Moya-Pérez, A., Luczynski, P., Renes, I.B., Wang, S., Borre, Y., Anthony Ryan, C., Knol, J., Stanton, C., Dinan, T.G. and Cryan, J.F., 2017. Intervention strategies for cesarean section-induced alterations in the microbiota-gut-brain axis. Nutrition Reviews 75: 225-240. https://doi.org/10.1093/nutrit/nuw069
Mugambi, M.N., Musekiwa, A., Lombard, M., Young, T. and Blaauw, R., 2012. Synbiotics, probiotics or prebiotics in infant formula for full term infants: a systematic review. Nutrition Journal 11: 81. https://doi.org/10.1186/1475-2891-11-81
Pan, K., Zhang, C. and Tian, J., 2021. The effects of different modes of delivery on the structure and predicted function of intestinal microbiota in neonates and early infants. Polish Journal of Microbiology 70: 45-55. https://doi.org/10.33073/pjm-2021-002
Pu, F., Guo, Y., Li, M., Zhu, H., Wang, S., Shen, X., He, M., Huang, C. and He, F., 2017. Yogurt supplemented with probiotics can protect the healthy elderly from respiratory infections: a randomized controlled open-label trial. Clinical Interventions in Aging 12: 1223-1231. https://doi.org/10.2147/cia.S141518
Quigley, E.M., 2011. Microflora modulation of motility. Journal of Neurogastroenterology and Motility 17: 140-147. https://doi.org/10.5056/jnm.2011.17.2.140
Salvatore, S., Pensabene, L., Borrelli, O., Saps, M., Thapar, N., Concolino, D., Staiano, A. and Vandenplas, Y., 2018. Mind the gut: probiotics in paediatric neurogastroenterology. Beneficial Microbes 9: 883-898. https://doi.org/10.3920/bm2018.0013
Sestito, S., DâAuria, E., Baldassarre, M.E., Salvatore, S., Tallarico, V., Stefanelli, E., Tarsitano, F., Concolino, D. and Pensabene, L., 2020. The role of prebiotics and probiotics in prevention of allergic diseases in infants. Frontiers in Pediatrics 8: 583946. https://doi.org/10.3389/fped.2020.583946
Squires, J., Twombly, E., Bricker, D. and Potter, L., 2009. ASQ-3 userâs guide. Paul H Brookes Publishing Co., Baltimore, MD, USA.
'ASQ-3 userâs guide', ().
Szajewska, H. and Chmielewska, A., 2013. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatrics 13: 185. https://doi.org/10.1186/1471-2431-13-185
Wang, S., Xun, Y., Ahern, G.J., Feng, L., Zhang, D., Xue, Y., Ross, R.P., Doolan, A.M., Stanton, C. and Zhu, H., 2021. A randomized, double blind, parallel, placebo-controlled study to investigate the efficacy of Lactobacillus paracasei N1115 in gut development of young children. Food Science and Nutrition 9: 6020-6030. https://doi.org/10.1002/fsn3.2533
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
Wang, S., Zhu, H., He, F., Luo, Y., Kang, Z., Lu, C., Feng, L., Lu, X., Xue, Y. and Wang, H., 2014. Whole genome sequence of the probiotic strain Lactobacillus paracasei N1115, isolated from traditional Chinese fermented milk. Genome Announcements 2: e00059-00014. https://doi.org/10.1128/genomeA.00059-14
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
Yao, F., Jia, R., Huang, H., Yu, Y., Mei, L., Bai, L., Ding, Y. and Zheng, P., 2019. Effect of Lactobacillus paracasei N1115 and fructooligosaccharides in nonalcoholic fatty liver disease. Archives of Medical Science 15: 1336-1344. https://doi.org/10.5114/aoms.2019.86611
Zeevenhooven, J., Koppen, I.J. and Benninga, M.A., 2017. The New Rome IV criteria for functional gastrointestinal disorders in infants and toddlers. Pediatric Gastroenterology, Hepatology and Nutrition 20: 1-13. https://doi.org/10.5223/pghn.2017.20.1.1
Zhang, Y., Pu, F., Cheng, R., Guo, J., Shen, X., Wang, S., Zhu, H., Zhang, X., Cheng, G., Li, M. and He, F., 2020. Effect of heat-inactivated Lactobacillus paracasei N1115 on microbiota and gut-brain axis related molecules. Bioscience of Microbiota, Food and Health 39: 89-99. https://doi.org/10.12938/bmfh.2019-025
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|---|---|---|---|
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| å ¨ææµè§æ¬¡æ° | 723 | 229 | 24 |
| PDFä¸è½½æ¬¡æ° | 512 | 203 | 15 |
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 Lacticaseibacillus paracasei 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 L. paracasei N1115 (2Ã1010 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 à time effect on stool frequency (P=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 (P=0.035 at week 9; P=0.048 at week 10; P=0.026 at week 12). The use of L. paracasei N1115 also reduced the incidence rate of constipation (Incidence rate ratio (IRR): 0.120; 95% confidence interval (CI): 0.015, 0.967; P=0.046) and abdominal pain (IRR: 0.562; 95% CI: 0.358, 0.882; P=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 L. paracasei N1115 is safe and well-tolerated in caesarean-born children aged 6-24 months. Furthermore, it may ameliorate gastrointestinal function to some extent.
| å ¨é¨æé´ | è¿å»ä¸å¹´ | è¿å»30天 | |
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