Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study

<i>Lactobacillus paracasei</i> N1115 (Lp N1115) was isolated from fermented milk products. The administration of Lp N1115 is safe and well tolerated in Chinese children, but its effectiveness among young Chinese children is still unclear. To investigate the efficacy of Lp N1115 as a prob...

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Main Authors: Pin Li, Zhongxia Ren, Junxiu Zhou, Ai Zhao, Shijie Wang, Yiping Xun, Hua Jiang, Peiyu Wang, Qingbin Yuan, Yumei Zhang
Format: Article
Language:English
Published: MDPI AG 2023-04-01
Series:Nutrients
Subjects:
Online Access:https://www.mdpi.com/2072-6643/15/8/1970
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author Pin Li
Zhongxia Ren
Junxiu Zhou
Ai Zhao
Shijie Wang
Yiping Xun
Hua Jiang
Peiyu Wang
Qingbin Yuan
Yumei Zhang
author_facet Pin Li
Zhongxia Ren
Junxiu Zhou
Ai Zhao
Shijie Wang
Yiping Xun
Hua Jiang
Peiyu Wang
Qingbin Yuan
Yumei Zhang
author_sort Pin Li
collection DOAJ
description <i>Lactobacillus paracasei</i> N1115 (Lp N1115) was isolated from fermented milk products. The administration of Lp N1115 is safe and well tolerated in Chinese children, but its effectiveness among young Chinese children is still unclear. To investigate the efficacy of Lp N1115 as a probiotic to enhance gut development in Chinese infants and toddlers born by cesarean section, 109 healthy and cesarean-delivered infants aged 6–24 months were recruited for a 12-week randomized, placebo-controlled trial, with 101 finally completing the study. Saliva and stool samples were collected and detected at weeks 0, 4, 8, and 12 of the intervention. Statistical analyses were performed by using a per-protocol (PP) approach. After 12 weeks of intervention, the fecal pH in the control group increased (<i>p</i> = 0.003), while the fecal pH in the experimental group did not change. Salivary cortisol decreased from baseline in the experimental group (<i>p</i> = 0.023), while the control group showed little change. In addition, Lp N1115 increased the fecal sIgA content of infants aged 6–12 months (<i>p</i> = 0.044) but had no obvious effect on fecal calprotectin and saliva sIgA. At week 4, the increase in <i>Lactobacillus</i> relative to baseline was higher in the experimental group than in the control group (<i>p</i> = 0.019). Further analysis showed a trend toward a higher detection rate of <i>Lactobacillus</i> in the experimental group than in the control group (<i>p</i> = 0.039). In conclusion, Lp N1115 was able to enhance the content of <i>Lactobacillus</i> and maintain fecal pH levels. Its beneficial effects on gut development were more obvious in 6–12-month-old infants.
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spelling doaj.art-2bab52e23ee44552a6919d3e4e5a63c02023-11-17T20:47:05ZengMDPI AGNutrients2072-66432023-04-01158197010.3390/nu15081970Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled StudyPin Li0Zhongxia Ren1Junxiu Zhou2Ai Zhao3Shijie Wang4Yiping Xun5Hua Jiang6Peiyu Wang7Qingbin Yuan8Yumei Zhang9Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, ChinaDepartment of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, ChinaDepartment of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, ChinaVanke School of Public Health, Tsinghua University, Beijing 100084, ChinaShijiazhuang Junlebao Dairy Co., Ltd., Shijiazhuang 050221, ChinaShijiazhuang Junlebao Dairy Co., Ltd., Shijiazhuang 050221, ChinaSchool of Nursing, Peking University, Beijing 100091, ChinaDepartment of Social Medicine and Health Education, School of Public Health, Peking University, Beijing 100191, ChinaShijiazhuang Junlebao Dairy Co., Ltd., Shijiazhuang 050221, ChinaDepartment of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China<i>Lactobacillus paracasei</i> N1115 (Lp N1115) was isolated from fermented milk products. The administration of Lp N1115 is safe and well tolerated in Chinese children, but its effectiveness among young Chinese children is still unclear. To investigate the efficacy of Lp N1115 as a probiotic to enhance gut development in Chinese infants and toddlers born by cesarean section, 109 healthy and cesarean-delivered infants aged 6–24 months were recruited for a 12-week randomized, placebo-controlled trial, with 101 finally completing the study. Saliva and stool samples were collected and detected at weeks 0, 4, 8, and 12 of the intervention. Statistical analyses were performed by using a per-protocol (PP) approach. After 12 weeks of intervention, the fecal pH in the control group increased (<i>p</i> = 0.003), while the fecal pH in the experimental group did not change. Salivary cortisol decreased from baseline in the experimental group (<i>p</i> = 0.023), while the control group showed little change. In addition, Lp N1115 increased the fecal sIgA content of infants aged 6–12 months (<i>p</i> = 0.044) but had no obvious effect on fecal calprotectin and saliva sIgA. At week 4, the increase in <i>Lactobacillus</i> relative to baseline was higher in the experimental group than in the control group (<i>p</i> = 0.019). Further analysis showed a trend toward a higher detection rate of <i>Lactobacillus</i> in the experimental group than in the control group (<i>p</i> = 0.039). In conclusion, Lp N1115 was able to enhance the content of <i>Lactobacillus</i> and maintain fecal pH levels. Its beneficial effects on gut development were more obvious in 6–12-month-old infants.https://www.mdpi.com/2072-6643/15/8/1970probioticyoung childrencesarean section<i>Lacticaseibacillus</i>
spellingShingle Pin Li
Zhongxia Ren
Junxiu Zhou
Ai Zhao
Shijie Wang
Yiping Xun
Hua Jiang
Peiyu Wang
Qingbin Yuan
Yumei Zhang
Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study
Nutrients
probiotic
young children
cesarean section
<i>Lacticaseibacillus</i>
title Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study
title_full Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study
title_fullStr Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study
title_full_unstemmed Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study
title_short Effect of <i>Lacticaseibacillus paracasei</i> N1115 on Immunomodulatory and Gut Microbial Composition in Young Children: A Randomized, Placebo-Controlled Study
title_sort effect of i lacticaseibacillus paracasei i n1115 on immunomodulatory and gut microbial composition in young children a randomized placebo controlled study
topic probiotic
young children
cesarean section
<i>Lacticaseibacillus</i>
url https://www.mdpi.com/2072-6643/15/8/1970
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