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To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Sponsor: Min-Tze LIONG
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.
Key Details
Gender
All
Age Range
0 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
366
Start Date
2024-01-01
Completion Date
2026-06-30
Last Updated
2026-04-01
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic
One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient
Placebo
One sachet daily (2g) containing only maltodextrin as excipient
Locations (2)
Shanghai Sixth People's Hospital
Pudong, Shanghai Municipality, China
Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, Malaysia