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.
Term infants are 37≤ gestational age < 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0~12 months old)
Breastfed or mixed-fed healthy infants and young children, aged 0~3 (inclusive) years old, gender is not limited
The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention: Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Young Children)
Family primary guardians agree to collect fecal samples of infants and young children during this study
The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases
Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment of infants and young children
Infants and young children who are known to be allergic to the ingredients of probiotic products
In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study
Parallel
Probiotic
Dietary supplementOne sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient
Placebo
Dietary supplementOne sachet daily (2g) containing only maltodextrin as excipient
Allergy symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire
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.
Microbiota profiles of fecal samples in young children upon administration of probiotic or placebo as assessed via 16s rRNA and metagenomics gene sequencing
Differences in microbiota profiles in fecal sample of children upon administration of probiotic or placebo
Gut immune biomarkers of fecal samples in young children upon administration of probiotic or placebo as assessed via Enzyme-Linked Immunosorbent Assay (ELISA)
Differences in gut immune biomarkers in fecal sample of children upon administration of probiotic or placebo, such as secretory immunoglobulin A (sIgA).
Defecation frequency in children upon administration of probiotic or placebo as assessed via daily stool diary
Differences in defecation frequency (stools per day) in children upon administration of probiotic or placebo, assessed using a structured daily stool diary completed by parents/guardians.
Stool consistency (Bristol Stool Scale characteristics) in children upon administration of probiotic or placebo as assessed via standardized stool form classification
Differences in stool consistency in children upon administration of probiotic or placebo, assessed using the Bristol Stool Form Scale (type 1-7), with parents/guardians recording daily stool characteristics, where abnormal stools are characterized by types 1-2 (constipation) and types 6-7 (diarrhea).
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Min-Tze LIONG
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Shanghai 6th People's Hospital
Collaborator
