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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05965063
Other study ID # BifidobacteriumRJH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date February 28, 2024

Study information

Verified date June 2023
Source Ruijin Hospital
Contact XINQIONG WANG
Phone 0086-021-64370045
Email wxq11671@rjh.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date February 28, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Months to 12 Months
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bifidobacterium M-16V
Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.
Other:
allergy food avoidance
strict avoidance of the specific allergenic food

Locations

Country Name City State
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other The percentile number of weight at the 4th, 8th and 12th 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
Other 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
Other 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
Other 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
Other 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
Primary 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 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
Secondary 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
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