Clinical Trial

To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants

Recruiting Phase 2
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Record status
This record was last updated April 1, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-18.
Trial Details
NCT Number NCT07490587
Lead Sponsor Min-Tze LIONG
Collaborators: Shanghai 6th People's Hospital
Conditions Healthy Children
Enrollment 366 participants
Start Date 2024-01-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-01