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The Role of Bifidobacterium Intervention in Food Allergic Infants

NCT05965063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-04-04

No results posted yet for this study

Summary

Infant food protein allergy is the most common allergic disease in children, which can lead to infantile-specific dermatitis, intestinal inflammation, and so on. Dietary avoidance is a common strategy for food protein allergy in infants and young children. However, the hidden etiology of food protein allergy or multiple food allergies often leads to poor efficacy. The aim of this study is to observe the clinical effectiveness of Bifidobacterium intervention on food allergy.

Conditions

  • Food Allergy in Infants

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium M-16V

Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.

OTHER

allergy food avoidance

strict avoidance of the specific allergenic food

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • CHUNDI Xu · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • China

Study Locations

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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 NCT05965063 on ClinicalTrials.gov