The Role of Bifidobacterium Intervention in Food Allergic Infants

NCT05965063 | Completed

• 1 other identifier: BifidobacteriumRJH
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy in Infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The milk related symptom score at the 8th week

  Treatment for 8-week

• The milk related symptom score at 12th week

  Treatment for 12-week

Other Outcomes (6)

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

  Treatment for 4-week, 8-week and 12-week

• The percentile number of weight 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

  Treatment for 4-week, 8-week and 12-week

Study Arms (3)

Dietary avoidance for allergy food

OTHER

strict avoidance of the specific allergenic food

Other: allergy food avoidance

bifidobacterium intervention

EXPERIMENTAL

Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food

Dietary Supplement: Bifidobacterium M-16V

Healthy control

NO INTERVENTION

without intervention

Interventions

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.

bifidobacterium intervention

allergy food avoidance OTHER

strict avoidance of the specific allergenic food

Dietary avoidance for allergy food

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location

Study Officials

• CHUNDI Xu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 28, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)