To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
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
Sex
ALL
Min age
0 Months
Max age
36 Months
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
* Have not used antibiotics in the past month
* Have not used probiotics in the past three months
* Family primary guardians committed not to add additional Bifidobacterium dietary supplements to infants and young children during the intervention period
* The guardians of the enrolled subjects agree to participate in this interventional study and sign a written informed consent form, and are able to understand and fill in forms such as infant diaries as required
* Signed informed consent and willing to follow up at the time specified in the trial
Exclusion Criteria:
* 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
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.
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.
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