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Actively Recruiting

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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.

Age: 0Months - 36MonthsAll GendersPhase 2
2 locations