MedTrace Logo

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

NCT07490587 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Healthy Children

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

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Min-Tze LIONG

    lead OTHER

Principal Investigators

  • Jinping Zhang, MD · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China
  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490587 on ClinicalTrials.gov