The Role of Bifidobacterium Intervention in Food Allergic Infants

Shanghai Jiao Tong University

Status: Completed

Conditions: Food Allergy in Infants

Treatments: Dietary Supplement: Bifidobacterium M-16V; Other: allergy food avoidance

Study type: Interventional

Funder types: Other

Identifiers

NCT05965063

BifidobacteriumRJH

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Dietary avoidance for allergy food

Other group

Description:

strict avoidance of the specific allergenic food

Treatment:

Other: allergy food avoidance

bifidobacterium intervention

Experimental group

Description:

Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food

Treatment:

Dietary Supplement: Bifidobacterium M-16V

Healthy control

No Intervention group

Description:

without intervention