To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Allergy symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire — Day-0, Day-180
Differences in severity of allergy symptoms in children upon administration of probiotic or placebo, assessed using a hospital-based clinical questionnaire, that captures the frequency and duration of symptoms over the observation period, where composite scores is the cumulative number and duration of reported episodes, with lower values indicating a lower overall symptom burden and better respiratory status.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Sixth People's Hospital | Pudong | Shanghai Municipality | Recruiting |
| Universiti Sains Malaysia | Pulau Pinang | Pulau Pinang | Not Yet Recruiting |
More Min-Tze LIONG trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07490587 on ClinicalTrials.gov ↗ ← All trials in China