Food Allergy in InfantsNCT05965063
The Role of Bifidobacterium Intervention in Food Allergic Infants
A study testing Bifidobacterium M-16V and allergy food avoidance in people with Food Allergy in Infants, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy in Infants
- What is being tested?
- Bifidobacterium M-16V and allergy food avoidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 021
About this study
Official title: 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.
- Conditions
- Food Allergy in Infants
- Being tested
- Bifidobacterium M-16V, allergy food avoidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium M-16VDietary supplement
Bifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks.
allergy food avoidanceOther
strict avoidance of the specific allergenic food
| Study group | Role | What they receive |
|---|---|---|
| Dietary avoidance for allergy food | Other | strict avoidance of the specific allergenic food Receives: Other: allergy food avoidance |
| bifidobacterium intervention | Experimental | Bifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food Receives: Dietary Supplement: Bifidobacterium M-16V |
| Healthy control | No intervention | without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Treatment for 4-week
Secondary outcomes (2)
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.
Measured: 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.
Measured: Treatment for 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in InfantsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHUNDI Xu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965063
- Sponsor's protocol ID
- BifidobacteriumRJH
- Status last verified
- Mar 2025
- First submitted
- 24 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Bifidobacterium on the Infants With Food Allergic
- ClinicalTrials.gov ID
- NCT05965063
- Acronym / sponsor ID
- BifidobacteriumRJH
- Conditions
- Food Allergy in Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary avoidance for allergy food | Other | Other: allergy food avoidancestrict avoidance of the specific allergenic food |
| bifidobacterium intervention | Experimental | Dietary Supplement: Bifidobacterium M-16VBifidobacterium M-16V for 12 weeks while strictly avoidance of the specific allergenic food |
| Healthy control | No intervention | –without intervention |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium M-16VBifidobacterium M-16V was dosed at 10 billion colony forming unit (CFU) (equal to 6 drops)/day for 12 weeks. | Dietary supplement | bifidobacterium intervention |
| allergy food avoidancestrict avoidance of the specific allergenic food | Other | Dietary avoidance for allergy food |
Primary outcome
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.
2 secondary outcomes
The milk related symptom score at the 8th week
Time frame: Treatment for 8-week
The milk related symptom score at 12th week
Time frame: Treatment for 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Food Allergy in Infants
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Slow Multiallergen Oral Immunotherapy in Young Children
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Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHUNDI Xu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium M-16V and allergy food avoidance in people with Food Allergy in Infants, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The milk related symptom score at the 4th week (time frame: Treatment for 4-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.