Back to resultsThe Role of Bifidobacterium Intervention in Food Allergic Infants
Primary Purpose
Food Allergy in Infants
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bifidobacterium M-16V
allergy food avoidance
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergy in Infants
Eligibility Criteria
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;
Sites / Locations
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
No Intervention
Arm Label
Dietary avoidance for allergy food
bifidobacterium intervention
Healthy control
Arm Description
strict avoidance of the specific allergenic food
Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food
without intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05965063
Brief Title
The Role of Bifidobacterium Intervention in Food Allergic Infants
Official Title
Evaluation of the Influence of Bifidobacterium on the Infants With Food Allergic
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary avoidance for allergy food
Arm Type
Other
Arm Description
strict avoidance of the specific allergenic food
Arm Title
bifidobacterium intervention
Arm Type
Experimental
Arm Description
Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
without intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium M-16V
Intervention Description
Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
allergy food avoidance
Intervention Description
strict avoidance of the specific allergenic food
Primary Outcome Measure Information:
Title
The milk related symptom score at the 4th week
Description
Compare the clinical symptoms of infants at the 4th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
Time Frame
Treatment for 4-week
Secondary Outcome Measure Information:
Title
The milk related symptom score at the 8th week
Description
Compare the clinical symptoms of infants at the 8th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
Time Frame
Treatment for 8-week
Title
The milk related symptom score at 12th week
Description
Compare the clinical symptoms of infants at the 12th week by milk-related symptom score (0-33) and higher scores mean a worse outcome.
Time Frame
Treatment for 12-week
Other Pre-specified Outcome Measures:
Title
The percentile number of height at the 4th, 8th and12th week
Description
Compare the Percentile number of height of infants at the 4th, 8th and 12th week
Time Frame
Treatment for 4-week, 8-week and 12-week
Title
The percentile number of weight at the 4th, 8th and 12th week
Description
Compare the Percentile number of weight of infants at the 4th, 8th and 12th week
Time Frame
Treatment for 4-week, 8-week and 12-week
Title
The percentile number of head circumference at the 4th, 8th and 12th week
Description
Compare the Percentile number of head circumference of infants at the 4th, 8th and 12th week
Time Frame
Treatment for 4-week, 8-week and 12-week
Title
The composition of intestinal microbiome
Description
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
Time Frame
Treatment for 4-week, 8-week and 12-week
Title
The composition of intestinal microbiome metabolites
Description
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.
Time Frame
Treatment for 4-week, 8-week and 12-week
Title
the messenger ribonucleic acid (mRNA) expression of blood
Description
The mRNA expression of blood will be detected and analyzed by blood RNA-seq at the 12th week
Time Frame
Treatment for 12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XINQIONG WANG
Phone
0086-021-64370045
Ext
600905
Email
wxq11671@rjh.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yu
Phone
0086-021-64370045
Ext
600905
Email
yy11635@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHUNDI Xu
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Bifidobacterium Intervention in Food Allergic Infants
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