{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T06:20:41Z","timestamp":1773037241619,"version":"3.50.1"},"reference-count":35,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T00:00:00Z","timestamp":1773014400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Nutr."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      The early postnatal period is a critical window for shaping the gut microbiota, which plays a pivotal role in immune maturation, infection resistance, and metabolic programming. Disruptions to this process may predispose infants to infections and allergic or metabolic disorders. Probiotics such as\n                      <jats:italic>Bifidobacterium infantis<\/jats:italic>\n                      have shown promise in modulating gut microbial ecology and immune function, but strain-specific and mechanistic evidence in infants remains limited. This study aimed to evaluate the effects of\n                      <jats:italic>B. infantis<\/jats:italic>\n                      YLGB-1496 supplementation on clinical outcomes, immune markers, and gut microbiota composition in healthy infants below one year of age.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In a 12-week, randomized, double-blind, placebo-controlled trial, 119 healthy infants were enrolled (\n                      <jats:italic>B. infantis<\/jats:italic>\n                      YLGB-1496\n                      <jats:italic>n<\/jats:italic>\n                      =59, placebo\n                      <jats:italic>n<\/jats:italic>\n                      =60). Participants received one daily sachet of\n                      <jats:italic>B. infantis<\/jats:italic>\n                      YLGB-1496 (1 \u00d7 10\u00b9\u2070 CFU) or placebo. Clinical outcomes for respiratory health and gastrointestinal (GI) health were assessed via validated questionnaires. Oral and fecal samples were collected for analysis of sIgA, cortisol, and cytokines (TNF-\u03b1, IFN-\u03b3, IL-1\u03b2, IL-10, calprotectin). Gut microbiota was profiled by 16S rRNA sequencing, and diversity indices and taxonomic shifts were analyzed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Compared with placebo,\n                      <jats:italic>B. infantis<\/jats:italic>\n                      YLGB-1496 supplementation was associated with consistent numerical reductions in respiratory symptom days, although these did not remain statistically significant after false discovery rate (FDR) adjustment. In contrast, gastrointestinal outcomes showed robust improvements after FDR correction, including reduced stomach ache (\n                      <jats:italic>q<\/jats:italic>\n                      = 0.010), lower diarrhea incidence (\n                      <jats:italic>q<\/jats:italic>\n                      &amp;lt; 0.001), and fewer diarrhea-related clinical visits (\n                      <jats:italic>q<\/jats:italic>\n                      &amp;lt; 0.001). Fecal sIgA remained elevated in the\n                      <jats:italic>B. infantis<\/jats:italic>\n                      YLGB-1496 group (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.138 vs\n                      <jats:italic>P<\/jats:italic>\n                      = 0.000 in placebo), accompanied by increased IL-10 (\n                      <jats:italic>P<\/jats:italic>\n                      &amp;lt; 0.001) and reduced IL-1\u03b2 (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.002). Oral sIgA was enhanced (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.001), while cortisol declined similarly in both groups. Microbiota analysis revealed enrichment of beneficial taxa in the\n                      <jats:italic>B. infantis<\/jats:italic>\n                      YLGB-1496 group with concurrent reductions in pathobionts. In contrast, the placebo group exhibited increases in Campylobacter,\n                      <jats:italic>Staphylococcus<\/jats:italic>\n                      , and\n                      <jats:italic>Desulfovibrio desulfuricans<\/jats:italic>\n                      , and decreases in\n                      <jats:italic>Faecalibacterium prausnitzii<\/jats:italic>\n                      and\n                      <jats:italic>Anaerostipes caccae<\/jats:italic>\n                      , indicative of dysbiosis. These compositional changes support improved gut barrier function and immune development.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:uri>https:\/\/clinicaltrials.gov\/study\/NCT05794815?term=NCT05794815&amp;amp;rank=1<\/jats:uri>\n                      , Identifier: NCT05794815.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fnut.2026.1746679","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T05:30:19Z","timestamp":1773034219000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Probiotic improves respiratory and gastrointestinal health, immune homeostasis, and gut microbiota composition in infants: a randomized controlled trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Mageswaran","family":"Uma Mageswary","sequence":"first","affiliation":[{"name":"School of Industrial Technology, Universiti Sains Malaysia","place":["Gelugor, Pulau Pinang, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lan","family":"Hanglian","sequence":"additional","affiliation":[{"name":"National Technology Innovation Center for Dairy","place":["Hohhot, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pin","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University Health Science Center","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rocky Vester","family":"Richmond","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Universiti Kebangsaan Malaysia Medical Centre, Faculty of Medicine, Universiti Kebangsaan Malaysia","place":["Kuala Lumpur, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusof","family":"Azianey","sequence":"additional","affiliation":[{"name":"Kepala Batas Health Clinic","place":["Kepala Batas, Pulau Pinang, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joo Shun","family":"Tan","sequence":"additional","affiliation":[{"name":"School of Industrial Technology, Universiti Sains Malaysia","place":["Gelugor, Pulau Pinang, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min-Tze","family":"Liong","sequence":"additional","affiliation":[{"name":"School of Industrial Technology, Universiti Sains Malaysia","place":["Gelugor, Pulau Pinang, Malaysia"]},{"name":"Laboratory of Microbiology, Immunology, and Metabolism, DiPROBIO (Shanghai) Co., Ltd","place":["Shanghai, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adli","family":"Ali","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Universiti Kebangsaan Malaysia Medical Centre, Faculty of Medicine, Universiti Kebangsaan Malaysia","place":["Kuala Lumpur, Malaysia"]},{"name":"Research Center, Hospital Tunku Ampuan Besar Tuanku Aishah Rohani, Universiti Kebangsaan Malaysia Specialist Children\u2019s Hospital","place":["Kuala Lumpur, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mishaleni","family":"Vejayantheran","sequence":"additional","affiliation":[{"name":"School of Industrial Technology, Universiti Sains Malaysia","place":["Gelugor, Pulau Pinang, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiang","family":"Hua","sequence":"additional","affiliation":[{"name":"School of Nursery, Peking University Health Science Center","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"He","family":"Jian","sequence":"additional","affiliation":[{"name":"National Technology Innovation Center for Dairy","place":["Hohhot, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Intan Juliana","family":"Abd Hamid","sequence":"additional","affiliation":[{"name":"Primary Immunodeficiency Diseases Group, Department of Clinical Medicine, Pusat Kanser Tun Abdullah Ahmad Badawi, Universiti Sains Malaysia","place":["Kepala Batas, Pulau Pinang, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fahisham","family":"Taib","sequence":"additional","affiliation":[{"name":"Paediatric Department, School of Medical Sciences, Universiti Sains Malaysia","place":["Kubang Kerian, Kelantan, Malaysia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yumei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Food Hygiene, School of Public Health, Peking University Health Science Center","place":["Beijing, China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,3,9]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"690073","DOI":"10.3389\/fnut.2021.690073","article-title":"How early-life gut microbiota alteration sets trajectories for health and inflammatory bowel disease?","volume":"8","author":"Guo","year":"2021","journal-title":"Front Nutr"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"103475","DOI":"10.1016\/j.ebiom.2021.103475","article-title":"Early-life gut microbiota and its connection to metabolic health in children: perspective on ecological drivers and need for quantitative approach","volume":"69","author":"Jian","year":"2021","journal-title":"EBioMedicine"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"212","DOI":"10.1111\/nbu.12334","article-title":"Probiotics for human 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IL-10 and IL-4 suppress cytokine synthesis by different mechanisms","volume":"270","author":"Wang","year":"1995","journal-title":"J Biol Chem"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"151","DOI":"10.1002\/bjs.6454","article-title":"Sulphate-reducing bacteria and hydrogen sulphide in the aetiology of ulcerative colitis","volume":"96","author":"Rowan","year":"2009","journal-title":"J Br Surg"}],"container-title":["Frontiers in Nutrition"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fnut.2026.1746679\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T05:30:21Z","timestamp":1773034221000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fnut.2026.1746679\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,9]]},"references-count":35,"alternative-id":["10.3389\/fnut.2026.1746679"],"URL":"https:\/\/doi.org\/10.3389\/fnut.2026.1746679","relation":{},"ISSN":["2296-861X"],"issn-type":[{"value":"2296-861X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,9]]},"article-number":"1746679"}}