The Role of Bifidobacterium Intervention in Food Allergic Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy in Infants
• Intervention / Treatment: Other: allergy food avoidance; Dietary supplement: Bifidobacterium M-16V

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy control; without intervention
Other: Dietary avoidance for allergy food; strict avoidance of the specific allergenic food	Other: allergy food avoidance; strict avoidance of the specific allergenic food
Experimental: bifidobacterium intervention; Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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 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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Chundi Xu, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: BifidobacteriumRJH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No