Bifidobacterium XLTG11 to support growth, immune health, and reduce allergies in infants at higher allergy risk
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
This trial tests whether daily Bifidobacterium animalis subsp. lactis XLTG11 for 180 days can reduce allergic, respiratory, and gastrointestinal symptoms and change gut microbiome and immune markers in infants under 3 with higher allergy risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 0 Months to 36 Months |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Pudong, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT07490587 on ClinicalTrials.gov |
What this trial studies
This Phase 2, 180-day randomized, double-blind, placebo-controlled trial enrolls healthy term infants and young children under 3 years with an elevated allergy risk score. Participants receive daily Bifidobacterium animalis subsp. lactis XLTG11 or placebo and are monitored for incidence and day-level burden of allergic, respiratory, and gastrointestinal symptoms. Fecal samples collected before and after the intervention undergo shotgun metagenomic sequencing to profile microbiome composition and functional pathways (KEGG, COG, GO) and to measure mucosal immune markers (β-defensin 2, LL-37, calprotectin, sIgA). Clinical outcomes will be linked to microbial and immune changes to explore potential mechanisms of benefit.
Who should consider this trial
Good fit: Healthy term infants and young children aged 0–3 years with an allergy risk score ≥6 who have not used antibiotics in the past month or probiotics in the past three months, and whose caregivers agree to fecal sample collection and to avoid additional Bifidobacterium supplements during the study.
Not a fit: Preterm or low birth weight infants, children who recently used antibiotics or probiotics, or those without an elevated allergy risk score are unlikely to benefit from this protocol's findings.
Why it matters
Potential benefit: If successful, this could reduce how often and how severely high-risk infants experience allergic, respiratory, and gastrointestinal symptoms and strengthen mucosal immune defenses.
How similar studies have performed: Prior probiotic trials have shown mixed, sometimes modest benefits for eczema and some gastrointestinal symptoms, but evidence varies by strain and the specific XLTG11 strain has limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Pudong, Shanghai Municipality and 1 other locations
- Shanghai Sixth People's Hospital — Pudong, Shanghai Municipality, China (Recruiting)
- Universiti Sains Malaysia — Pulau Pinang, Pulau Pinang, Malaysia (Not_yet_recruiting)
Study contacts
- Principal investigator: Jinping Zhang, MD — Shanghai 6th People's Hospital
- Study coordinator: Min Tze Liong, Ph.D.
- Email: mintze.liong@usm.my
- Phone: 6046532114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.