HealthNCT06854536
A Study on the Changes and Prognosis of Intestinal Microbiota and Function in Infants With Food Allergies
An observational study of Health and Children, run by Ruijin Hospital at 1 site in China.
Trial summary
Microorganisms maintain a complex interrelationship with the human body, influencing each other. In recent years, people have gradually realized that the formation of the pediatric microecosystem is closely related to the development of gastrointestinal and even systemic immunity in children. Read more about this study
- Who is it for?
- Ages 1 month to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Health, Children, Gut Microbiota
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Feb 2028
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Diagnosed with food allergy children aged 1-36 months old
Who may be able to join
- Children aged 1-36 months old
- Both men and women;
- The child's legal guardian signed the informed consent to participate in the study.
- The legal guardian of the child commits to follow the study procedures and cooperate with the entire study process
Who cannot join
- Probiotics or antibiotics within 1 month
- Associated with clinically significant abnormalities in liver and kidney function, nervous system, respiratory system, and coagulation function as determined by the investigator
- Unstable vital signs;
- Have other underlying medical conditions
- Individuals deemed unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Microorganisms maintain a complex interrelationship with the human body, influencing each other. In recent years, people have gradually realized that the formation of the pediatric microecosystem is closely related to the development of gastrointestinal and even systemic immunity in children. The establishment of the pediatric microecosystem during childhood has significant implications for various diseases in adulthood. They are crucial for the host's nutrition, metabolism, resistance to pathogens, and immune function. Increasing evidence supports the association between gut microbiota abnormalities and the pathophysiology of food allergies, but the conclusions of existing clinical efficacy studies remain controversial. Previous research by the team has found that the gut microbiome has a clear impact on the occurrence and development of digestive and allergic diseases in children.
Read the detailed description
Food allergy is a harmful immunological response to the ingestion of food proteins , causing various symptoms in multiple parts of the body, such as skin itching, redness, and hives; asthma and coughing in the respiratory tract; and nausea, vomiting, and diarrhea in the gastrointestinal tract. In severe cases, it can even lead to shock and death. FA primarily affects infants and young children, with a prevalence rate of up to 10% in developed countries. A epidemiological survey in China showed that the food allergy rate among children aged 0-36 months in eight cities was 6.53%, and the incidence rate has been increasing year by year. Currently, it is believed that FA in infancy is a risk factor for later eczema, allergic rhinitis, and asthma, which can severely impact children's growth and development and quality of life, increasing the burden on families and society. It has become a public health issue worldwide. Among infant food allergies, cow's milk and egg allergies are the most common. Cow's milk protein is the most commonly used protein source in ordinary infant formulas. Cow's milk protein allergy refers to an adverse reaction mediated by the immune mechanism caused by the body's response to cow's milk protein, which can be mediated by IgE, non-IgE, or both. Studies in some Chinese cities have shown that the prevalence of Cow's milk protein allergy among infants aged 0-3 years is approximately 0.83% to 3.5%. Since cow's milk protein is essential for infant growth and development, Cow's milk protein allergy can significantly affect children's growth and development and quality of life.
The pathogenesis of FA is not yet fully understood, but increasing evidence supports the involvement of abnormal gut microbiota in the pathophysiology of FA. Extensive basic research has found that certain probiotics play roles at multiple stages in the development of food allergies, including: In the intestinal lumen: regulating the structure of gut microbiota, increasing the production of secretory IgA, and modifying antigen peptides. At the intestinal mucosal level: improving intestinal mucosal permeability, stimulating the growth and differentiation of intestinal epithelial cells. At the submucosal level: regulating the function of the innate and adaptive immune systems, inducing oral tolerance, and affecting the function of the enteric neuroendocrine system. Studies have shown that bifidobacteria in the host gut can promote the development and maturation of the infant immune system, and their species composition and diversity have received significant attention regarding their impact on allergic diseases.
In summary, food allergies are relatively common in infancy and have been increasing annually. Therefore, this study aims to understand the changes in the gut microbiota and its metabolites in infants with food allergies, as well as the differences in gut microbiota between children with and without immune tolerance to food allergies, and to discover related gut microbial metabolites.
- Conditions
- Health, Children, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food-allergic children | Children diagnosed with food allergies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome analysis
The fecal samples from all participants will be collected and subjected to high-throughput metagenomic sequencing in order to elucidate the characteristics and composition of the intestinal microbiome in children with food allergies.
Measured: The time point of confirming food allergy and the age of 36 months
Intestinal microbiome metabolites analysis
This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MS) non-targeted metabolomics to analyze the metabolites of the intestinal microbiome.
Measured: The time point of confirming food allergy and the age of 36 months
Secondary outcomes (4)
Differences in clinical symptoms
The incidence of ariway allergy in children with food allergy at the age of 36 months.
Measured: 36 months of age
The percentile number of height of children at different groups
Compare the Percentile number of height of children with diagnosed with food allergy and healthy children.
Measured: The time point of confirming food allergy and the age of 36 months
The percentile number of head circumference of children at different group
Compare the Percentile number of head circumference of children with diagnosed with food allergy and healthy children.
Measured: The time point of confirming food allergy and the age of 36 months
The percentile number of weight of children at different groups
Compare the Percentile number of weight of children with diagnosed with food allergy and healthy children.
Measured: The time point of confirming food allergy and the age of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854536
- Sponsor's protocol ID
- GMSF-001
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Changes and Prognosis of Intestinal Microbiota and Function in Infants With Food Allergies
- ClinicalTrials.gov ID
- NCT06854536
- Acronym / sponsor ID
- GMSF-001
- Conditions
- Health, Children, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 3 Mar 2025 (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.
Microorganisms maintain a complex interrelationship with the human body, influencing each other. In recent years, people have gradually realized that the formation of the pediatric microecosystem is closely related to the development of gastrointestinal and even systemic immunity in children. The establishment of the pediatric microecosystem during childhood has significant implications for various diseases in adulthood. They are crucial for the host's nutrition, metabolism, resistance to pathogens, and immune function. Increasing evidence supports the association between gut microbiota abnormalities and the pathophysiology of food allergies, but the conclusions of existing clinical efficacy studies remain controversial. Previous research by the team has found that the gut microbiome has a clear impact on the occurrence and development of digestive and allergic diseases in children.
Detailed description
Food allergy is a harmful immunological response to the ingestion of food proteins , causing various symptoms in multiple parts of the body, such as skin itching, redness, and hives; asthma and coughing in the respiratory tract; and nausea, vomiting, and diarrhea in the gastrointestinal tract. In severe cases, it can even lead to shock and death. FA primarily affects infants and young children, with a prevalence rate of up to 10% in developed countries. A epidemiological survey in China showed that the food allergy rate among children aged 0-36 months in eight cities was 6.53%, and the incidence rate has been increasing year by year. Currently, it is believed that FA in infancy is a risk factor for later eczema, allergic rhinitis, and asthma, which can severely impact children's growth and development and quality of life, increasing the burden on families and society. It has become a public health issue worldwide. Among infant food allergies, cow's milk and egg allergies are the most common. Cow's milk protein is the most commonly used protein source in ordinary infant formulas. Cow's milk protein allergy refers to an adverse reaction mediated by the immune mechanism caused by the body's response to cow's milk protein, which can be mediated by IgE, non-IgE, or both. Studies in some Chinese cities have shown that the prevalence of Cow's milk protein allergy among infants aged 0-3 years is approximately 0.83% to 3.5%. Since cow's milk protein is essential for infant growth and development, Cow's milk protein allergy can significantly affect children's growth and development and quality of life.
The pathogenesis of FA is not yet fully understood, but increasing evidence supports the involvement of abnormal gut microbiota in the pathophysiology of FA. Extensive basic research has found that certain probiotics play roles at multiple stages in the development of food allergies, including: In the intestinal lumen: regulating the structure of gut microbiota, increasing the production of secretory IgA, and modifying antigen peptides. At the intestinal mucosal level: improving intestinal mucosal permeability, stimulating the growth and differentiation of intestinal epithelial cells. At the submucosal level: regulating the function of the innate and adaptive immune systems, inducing oral tolerance, and affecting the function of the enteric neuroendocrine system. Studies have shown that bifidobacteria in the host gut can promote the development and maturation of the infant immune system, and their species composition and diversity have received significant attention regarding their impact on allergic diseases.
In summary, food allergies are relatively common in infancy and have been increasing annually. Therefore, this study aims to understand the changes in the gut microbiota and its metabolites in infants with food allergies, as well as the differences in gut microbiota between children with and without immune tolerance to food allergies, and to discover related gut microbial metabolites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food-allergic children | – | –Children diagnosed with food allergies |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Diagnosed with food allergy children aged 1-36 months old
Key inclusion criteria (4 listed)
- Children aged 1-36 months old
- Both men and women;
- The child's legal guardian signed the informed consent to participate in the study.
- The legal guardian of the child commits to follow the study procedures and cooperate with the entire study process
Key exclusion criteria (5 listed)
- Probiotics or antibiotics within 1 month
- Associated with clinically significant abnormalities in liver and kidney function, nervous system, respiratory system, and coagulation function as determined by the investigator
- Unstable vital signs;
- Have other underlying medical conditions
- Individuals deemed unsuitable for this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intestinal microbiome analysis
Time frame: The time point of confirming food allergy and the age of 36 months
The fecal samples from all participants will be collected and subjected to high-throughput metagenomic sequencing in order to elucidate the characteristics and composition of the intestinal microbiome in children with food allergies.
Intestinal microbiome metabolites analysis
Time frame: The time point of confirming food allergy and the age of 36 months
This will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MS) non-targeted metabolomics to analyze the metabolites of the intestinal microbiome.
4 secondary outcomes
Differences in clinical symptoms
Time frame: 36 months of age
The percentile number of height of children at different groups
Time frame: The time point of confirming food allergy and the age of 36 months
The percentile number of head circumference of children at different group
Time frame: The time point of confirming food allergy and the age of 36 months
The percentile number of weight of children at different groups
Time frame: The time point of confirming food allergy and the age of 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health and Children, 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Intestinal microbiome analysis (time frame: The time point of confirming food allergy and the age of 36 months). The study lists 2 primary outcomes in all. 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 3 Mar 2025.