The Role of Bifidobacterium Intervention in Food Allergic Infants

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Influence of Bifidobacterium on the Infants With Food Allergic

Conditions
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Food Allergy in Infants

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium M-16V
* Other: allergy food avoidance


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dietary avoidance for allergy food<br>strict avoidance of the specific allergenic food | Other: allergy food avoidance<br>* strict avoidance of the specific allergenic food<br>|
| Experimental: bifidobacterium intervention<br>Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food | Dietary Supplement: Bifidobacterium M-16V<br>* Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.<br>|
| No Intervention: Healthy control<br>without intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The milk related symptom score at the 4th 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. | Treatment for 4-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The milk related symptom score at the 8th 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. | Treatment for 8-week | 
| The milk related symptom score at 12th 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. | Treatment for 12-week |