Food Allergy in Infants
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium M-16V
Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.
OTHERallergy food avoidance
strict avoidance of the specific allergenic food
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The composition of intestinal microbiome | Treatment for 4-week, 8-week and 12-week | 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 |
| The percentile number of height at the 4th, 8th and12th week | Treatment for 4-week, 8-week and 12-week | Compare the Percentile number of height of infants at the 4th, 8th and 12th week |
| the messenger ribonucleic acid (mRNA) expression of blood | Treatment for 12-week | The mRNA expression of blood will be detected and analyzed by blood RNA-seq at the 12th week |
| The composition of intestinal microbiome metabolites | Treatment for 4-week, 8-week and 12-week | 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. |
| The percentile number of weight at the 4th, 8th and 12th week | Treatment for 4-week, 8-week and 12-week | Compare the Percentile number of weight of infants at the 4th, 8th and 12th week |
| The percentile number of head circumference at the 4th, 8th and 12th week | Treatment for 4-week, 8-week and 12-week | Compare the Percentile number of head circumference of infants at the 4th, 8th and 12th week |
Countries
China
Outcome results
None listed