The Role of Bifidobacterium Intervention in Food Allergic Infants

Food Allergy in Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965063
• Other study ID #: BifidobacteriumRJH
• Status: Recruiting
• Phase: N/A
• 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
• 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;

Related Conditions & MeSH terms

• Food Allergy in Infants
• Food Hypersensitivity

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