Recruiting

Bifidobacterium Animalis Subsp. Lactis XLTG11 for Reduced Allergy Risk in Infants

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 2 study aims to evaluate if Bifidobacterium Animalis Subsp. Lactis XLTG11 probiotic can prevent allergy symptoms in infants, as measured by a hospital-based clinical questionnaire.

What is being tested

Probiotic

+ Placebo

Dietary Supplement
Who is being recruted

Hypersensitivity

+ Immune System Diseases

Until 36 Months
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorMin-Tze LIONG
Study ContactMin Tze Liong, Ph.D.More contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on the effects of a specific probiotic, Bifidobacterium Animalis Subsp. Lactis XLTG11, on the growth, development, and immune function of infants. The research aims to understand how this probiotic might reduce the risk of allergies in healthy infants and young children under 3 years old. The study is important because early childhood is a critical time for the development of the gut microbiome and immune system. Imbalances during this period can lead to allergies, respiratory issues, and gastrointestinal disorders, which are common health problems in children worldwide. During the 180-day trial, participants receive either the probiotic or a placebo daily. The study measures the benefits of the probiotic across various health areas, including allergies, respiratory, and gastrointestinal symptoms. It also evaluates safety outcomes such as growth parameters and bowel habits. To understand how the probiotic works, the study uses advanced techniques like shotgun metagenomic sequencing to analyze changes in gut bacteria. It also measures certain immune markers to see how the probiotic might strengthen the body's natural defenses. The main goal is to determine if the probiotic can reduce allergy symptoms in children, as assessed through a hospital-based clinical questionnaire.

Official TitleTo Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants 
Principal SponsorMin-Tze LIONG
Study ContactMin Tze Liong, Ph.D.More contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

366 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 36 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypersensitivityImmune System Diseases

Criteria

9 inclusion criteria required to participate
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

Show More Criteria

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this group receive a daily sachet of a probiotic supplement. This supplement contains Bifidobacterium animalis subsp. lactis XLTG11, a type of beneficial bacteria, along with maltodextrin, a common food additive.

Group II

Placebo
One sachet daily (2 g) containing only maltodextrin as excipient

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Shanghai Sixth People's Hospital

Pudong, ChinaSee the location
Recruiting soon

Universiti Sains Malaysia

Pulau Pinang, Malaysia
Recruiting
2 Study Centers