Actively Recruiting
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Led by Min-Tze LIONG · Updated on 2026-04-01
366
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
Sponsors
M
Min-Tze LIONG
Lead Sponsor
S
Shanghai 6th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Term infants with gestational age between 37 and less than 42 weeks and birth weight between 2500g and 4000g (for 0 to 12 months old)
- Breastfed or mixed-fed healthy infants and young children aged 0 to 3 years old, any gender
- Allergy risk score of 6 or higher based on Infant Allergy Risk Assessment Table
- Family guardians agree to collect fecal samples during the study
- No antibiotic use in the past month
- No probiotic use in the past three months
- Family guardians agree not to add extra Bifidobacterium supplements during intervention
- Guardians agree to participate, understand, and complete required forms
- Signed informed consent and willingness to follow up as scheduled
You will not qualify if you...
- Mother has history of diabetes, hepatitis B, HIV, or other infectious diseases
- Child diagnosed with allergic diseases such as eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever at enrollment
- Child known to be allergic to probiotic ingredients
- Investigator judges child unsuitable for participation for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Sixth People's Hospital
Pudong, Shanghai Municipality, China, 201306
Actively Recruiting
2
Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, Malaysia, 11800
Not Yet Recruiting
Research Team
M
Min Tze Liong, Ph.D.
CONTACT
J
Jie Yuan, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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