The Role of Bifidobacterium Intervention in Food Allergic Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Food Allergy in Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dietary avoidance for allergy food

strict avoidance of the specific allergenic food

Group Type OTHER

allergy food avoidance

Intervention Type OTHER

strict avoidance of the specific allergenic food

bifidobacterium intervention

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

Group Type EXPERIMENTAL

Bifidobacterium M-16V

Intervention Type DIETARY_SUPPLEMENT

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

Healthy control

without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bifidobacterium M-16V

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

Intervention Type DIETARY_SUPPLEMENT

allergy food avoidance

strict avoidance of the specific allergenic food

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

0 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes