To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Min-Tze LIONG
366 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
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Interventions
One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient
One sachet daily (2g) containing only maltodextrin as excipient
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07490587