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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Healthy Children

In brief

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 facts

Study ID

NCT07490587

Run by

Min-Tze LIONG

People needed

366

Starts

2024-01-01

Expected to finish

2026-06-30

Last updated by the study team

2026-04-01

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shanghai Sixth People's Hospital — Pudong, Shanghai Municipality, China (enrolling)
• Universiti Sains Malaysia — Pulau Pinang, Pulau Pinang, Malaysia

Full record on ClinicalTrials.gov

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