The Role of Bifidobacterium Intervention in Food Allergic Infants

Not Applicable

Completed

• Conditions: Food Allergy in Infants
• Interventions: Dietary Supplement: Bifidobacterium M-16V; Other: allergy food avoidance

• Registration Number: NCT05965063
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-24
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-28
• Study Start: 2023-09-01
• Primary Completion: 2024-12-31
• Status Verified: 2025-03
• Study Completion: 2025-03-31
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 0 -12 months infant
• Infants that are allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg, soy or wheat) and is following an elimination diet to at least one of these allergens.

Exclusion Criteria

• Patients had used probiotics within 1 month prior to the study
• Allergy or intolerance to probiotics or their excipient
• Serious primary diseases of the cardiovascular, nervous, respiratory,hepatobiliary immunology，and endocrine systems;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bifidobacterium intervention	Bifidobacterium M-16V	Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food
Dietary avoidance for allergy food	allergy food avoidance	strict avoidance of the specific allergenic food

Primary Outcome Measures

Name	Time	Method
The milk related symptom score at the 4th week	Treatment for 4-week	Compare the clinical symptoms of infants at the 4th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
The milk related symptom score at the 8th week	Treatment for 8-week	Compare the clinical symptoms of infants at the 8th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
The milk related symptom score at 12th week	Treatment for 12-week	Compare the clinical symptoms of infants at the 12th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China