A Study on the Changes and Prognosis of Intestinal Microbiota and Function in Infants With Food Allergies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	1 Month - 36 Months
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06854536
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ruijin Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Health, Children, Gut Microbiota

Additional Details

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.

Arms & Interventions

Arms

: Food-allergic children

Children diagnosed with food allergies

Interventions

Contact a Trial Team

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International Sites

Shanghai, Shanghai, China

Status

Address

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, 200025

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