The Role of Bifidobacterium Intervention in Food Allergic Infants

Sponsor

Ruijin Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05965063

Collaborator

(none)

300

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

50.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Food Allergy in Infants	Dietary Supplement: Bifidobacterium M-16V Other: allergy food avoidance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Healthy control without intervention

Arm

Intervention/Treatment

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.

No Intervention: Healthy control

without intervention

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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 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
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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Months to 12 Months

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	021

Sponsors and Collaborators

Ruijin Hospital

Investigators

Principal Investigator: CHUNDI Xu, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT05965063

Other Study ID Numbers:

BifidobacteriumRJH

First Posted:

Jul 28, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Food Hypersensitivity

Study Results

No Results Posted as of Aug 3, 2023