Actively Recruiting
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth, Allergy Incidence, and Immune Function in Infants and Young Children
Led by Min-Tze LIONG · Updated on 2026-04-01
366
Participants Needed
2
Research Sites
N/A
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 research aims to study healthy infants and young children under 3 years old who have a higher risk of allergies. It evaluates the effects of daily supplementation with the probiotic Bifidobacterium animalis subsp. lactis XLTG11 compared to a placebo over 180 days. The study focuses on allergic, respiratory, and gastrointestinal symptoms and investigates how the probiotic may influence the gut microbiome and immune system during early development. Participants are randomly assigned to one of two groups: one receiving a daily sachet containing the probiotic (1 × 10¹⁰ CFU per 2 g dose) with maltodextrin, and the other receiving a placebo sachet with maltodextrin only. The intervention lasts for 180 days. Fecal samples are collected before and after treatment to analyze gut bacteria composition, functional pathways, and immune markers such as β-defensin 2, LL-37, calprotectin, and secretory IgA. During the study, caregivers will complete clinical questionnaires and maintain daily stool diaries to track allergy symptoms, stool frequency, and consistency. Researchers will measure growth and development using standardized anthropometric scores. Laboratory tests include metagenomic sequencing of fecal samples and immune biomarker analysis. The study aims to understand how the probiotic affects symptom burden, gut health, and immune function over the 180-day period.
CONDITIONS
Brief 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...
- Infants born at term between 37 and less than 42 weeks gestational age, with birth weight between 2500g and 4000g (applicable to 0-12 months old)
- Breastfed or mixed-fed healthy infants and young children aged 0 to 3 years (inclusive), any gender
- Allergy risk score of 6 or higher according to the Infant Allergy Risk Assessment Table
- Family guardians agree to fecal sample collection during the study
- No antibiotic use in the past month
- No probiotic use in the past three months
- Guardians committed not to add additional Bifidobacterium dietary supplements during the intervention
- Guardians agree to participate, provide informed consent, and can complete required forms such as infant diaries
- Willing to follow up at specified trial times
You will not qualify if you...
- Mother has a history of diabetes, hepatitis B, HIV, or other infectious diseases
- Infant or child diagnosed with allergic diseases (eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at enrollment
- Known allergy to probiotic product ingredients
- Any other reasons deemed by investigators that make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 180 days
Participants receive daily probiotic or placebo sachets to evaluate effects on growth, allergy incidence, and immune function.
Baseline visit and follow-up visit at Day 180
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.
J
Jie Yuan, M.Sc.
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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