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RECRUITING
NCT07490587
PHASE2

To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants

Sponsor: Min-Tze LIONG

View on ClinicalTrials.gov

Summary

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 gastrointestinal symptoms. To investigate potential mechanisms, fecal samples were collected pre- and post-intervention for shotgun metagenomic sequencing to analyze changes in gut microbiota composition, functional pathways (KEGG, COG, GO), and mucosal immune markers (β-defensin 2, LL-37, calprotectin, sIgA) associated with clinical improvements.

Key Details

Gender

All

Age Range

0 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

366

Start Date

2024-01-01

Completion Date

2026-06-30

Last Updated

2026-04-01

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Probiotic

One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient

DIETARY_SUPPLEMENT

Placebo

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

Locations (2)

Shanghai Sixth People's Hospital

Pudong, Shanghai Municipality, China

Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, Malaysia