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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary avoidance for allergy food | Other | strict avoidance of the specific allergenic food |
|
| bifidobacterium intervention | Experimental | Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food |
|
| Healthy control | No Intervention | without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium M-16V | Dietary Supplement | Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentile number of height at the 4th, 8th and12th week | Compare the Percentile number of height of infants at the 4th, 8th and 12th week | Treatment for 4-week, 8-week and 12-week |
| The percentile number of weight at the 4th, 8th and 12th week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHUNDI Xu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 021 | China |
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| allergy food avoidance | Other | strict avoidance of the specific allergenic food |
|
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 |
Compare the Percentile number of weight of infants at the 4th, 8th and 12th week
| Treatment for 4-week, 8-week and 12-week |
| The percentile number of head circumference at the 4th, 8th and 12th week | Compare the Percentile number of head circumference of infants at the 4th, 8th and 12th week | Treatment for 4-week, 8-week and 12-week |
| The composition of intestinal microbiome | All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics and composition of intestinal microbiome at the 4th, 8th and 12th week to analyze the intestinal microbiome composition | Treatment for 4-week, 8-week and 12-week |
| The composition of intestinal microbiome metabolites | This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MC) non-targeted metabolomics at the 4th, 8th and 12th week to analyze the intestinal microbiome metabolites. | Treatment for 4-week, 8-week and 12-week |
| the messenger ribonucleic acid (mRNA) expression of blood | The mRNA expression of blood will be detected and analyzed by blood RNA-seq at the 12th week | Treatment for 12-week |