Condition: Healthy Children · Sponsor: Min-Tze LIONG
This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. The primary clinical outcomes assessed are incidence and day-level burden of allergic, respiratory, and gastrointestinal symptoms. To investigate potential mechanisms, fecal samples were collected pre- and post-intervention for shotgun metagenomic sequencing to analyze changes in gut microbiota composition, functional pathways (KEGG, COG, GO), and mucosal immune markers (β-defensin 2, LL-37, calprotectin, sIgA) associated with clinical improvements.
This description comes directly from the study's public registry record.
Min Tze Liong, Ph.D. · 6046532114 · mintze.liong@usm.my
Jie Yuan, M.Sc. · peanut.yuan@diprobio.com
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| Shanghai Sixth People's Hospital | Pudong, Shanghai Municipality, China | Recruiting |
| Universiti Sains Malaysia | Pulau Pinang, Pulau Pinang, Malaysia | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07490587