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Completed

NCT Number: NCT05965063

The Role of Bifidobacterium Intervention in Food Allergic Infants

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.

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Key information

Conditions

Food Allergy in Infants

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Bifidobacterium M-16V

Dietary Supplement

Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.

allergy food avoidance

Other

strict avoidance of the specific allergenic food

Primary outcomes

  1. The milk related symptom score at the 4th week

    Time frame: 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 outcomes

  1. The milk related symptom score at the 8th week

    Time frame: 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.

  2. The milk related symptom score at 12th week

    Time frame: 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 outcomes

  1. The percentile number of height at the 4th, 8th and12th week

    Time frame: Treatment for 4-week, 8-week and 12-week

    Compare the Percentile number of height of infants at the 4th, 8th and 12th week

  2. The percentile number of weight at the 4th, 8th and 12th week

    Time frame: Treatment for 4-week, 8-week and 12-week

    Compare the Percentile number of weight of infants at the 4th, 8th and 12th week

  3. The percentile number of head circumference at the 4th, 8th and 12th week

    Time frame: 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

  4. The composition of intestinal microbiome

    Time frame: 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

  5. The composition of intestinal microbiome metabolites

    Time frame: 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.

  6. the messenger ribonucleic acid (mRNA) expression of blood

    Time frame: Treatment for 12-week

    The mRNA expression of blood will be detected and analyzed by blood RNA-seq at the 12th week

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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