Bifidobacterium XLTG11 to support growth, immune health, and reduce allergies in infants at higher allergy risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prevention with PMBL for recurrent RTIs in kids

  This study tests whether PMBL sublingual tablets can help prevent recurrent respiratory tract infections in children aged 3–12 compared to a placebo.

  Recruiting at 9 sites Phase 4 Lallemand Pharma AG · Bialystok and 9 other locations · NCT07578012

• Outdoor science education to improve learning and well-being in primary school children

  This project will test whether giving 5th and 6th grade students outdoor science lessons instead of indoor lessons helps their learning, connection to nature, eco-anxiety, and stress.

  Recruiting Université de Sherbrooke · Montreal, Quebec · NCT07147634

• Functional training versus dynamic play to improve motor skills, fitness, and balance in 7–10-year-old children

  This trial will test whether functional training or dynamic play better improves gross motor skills, physical fitness, and balance in healthy children aged 7–10.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07005440

• Translation of a mobility assessment tool for healthy children into Urdu

  This study is trying to translate a mobility assessment tool into Urdu to see if it can accurately measure how well healthy children aged 5-12 can move.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT06986720

• Comparing physical health in children with esophageal atresia and healthy peers

  This study looks at how the physical health of children with esophageal atresia compares to that of healthy kids to see how the condition affects things like strength, exercise, and overall well-being.

  Recruiting Hacettepe University · Ankara, Ankara · NCT06975982

• Hand and Bimanual Therapy in a VR game for children with cerebral palsy

  This study tests whether a VR-based hand therapy program called HABIT-VR can improve hand function in children aged 6–17 with cerebral palsy, compared to a standard VR HABIT-VR approach.

  Recruiting University of Nebraska · Omaha, Nebraska · NCT06818877

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.