What is Bifidobacterium animalis subsp. lactis XLTG11 studying for healthy children?

This clinical trial is studying the effects of the probiotic Bifidobacterium animalis subsp. lactis XLTG11 on growth, allergy symptoms, and immune function in healthy infants and young children at risk of allergies. Researchers want to understand how the probiotic may influence gut health and reduce symptoms related to allergies, respiratory, and gastrointestinal issues.

Who may be eligible for this healthy children clinical trial?

Healthy infants and young children aged 0 to 36 months who are breastfed or mixed-fed and have a higher risk of allergies may be eligible. Children must not have used antibiotics in the past month or probiotics in the past three months, and cannot have diagnosed allergic diseases at enrollment. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy children clinical trial?

Study-related care, including the probiotic or placebo and all trial visits, is provided at no cost. However, personal travel expenses or other costs may vary and are not guaranteed to be covered. Participants and families should plan accordingly for any travel or related expenses.

Actively Recruiting

Phase 2

Age: 0Months - 36Months

All Genders

Healthy Volunteers

ID07490587

Study of Bifidobacterium Animalis Subsp. Lactis XLTG11 Probiotic Effects on Growth, Allergy Risk, and Immune Health in Infants and Young Children Under 3 Years

Led by Min-Tze LIONG · Updated on 2026-04-01

366

Participants Needed

Research Sites

N/A

Total Duration

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 10 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 -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

Age: 0Months - 36Months

All Genders

Healthy Volunteers

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

Research Team

Min Tze Liong, Ph.D.

Jie Yuan, M.Sc.

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Study of Bifidobacterium Animalis Subsp. Lactis XLTG11 Probiotic Effects on Growth, Allergy Risk, and Immune Health in Infants and Young Children Under 3 Years

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria