To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Recruiting
Phase 2
Interventional Study
Healthy Children
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 0 Months – 36 Months
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 366 (estimated)
- Sponsor
- Min-Tze LIONG · Other
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About This Trial
This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. The primary clinical outcomes assessed are incidence and day-level burden of allergic, respiratory, and gastroi…
Trial Locations
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Eligibility 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 …
Contacts