Food allergy
Conditions
Interventions
Placebo group:Placebo (maltodextrin) given
Probiotics group:Probiotics (HN001+M-16V+CECT5716) given
Sponsors
Jiangxi Provincial Children’s Hospital
Eligibility
Sex/Gender
All
Age
3 Months to 3 Years
Inclusion criteria
Inclusion criteria: (1) All participants (parents) sign an informed consent form; (2) Age range from 3 months to 3 years old; (3) Good compliance, able to comply with clinical trial requirements and promise to cooperate with the research throughout the entire trial period; (4) Serum specific IgE = 0.35kUA/L or skin prick positive; (5) Appearing obvious allergic symptoms and diagnosed as food allergy by a specialist.
Exclusion criteria
Exclusion criteria: (1) Having gastrointestinal diseases such as diarrhea, immune diseases, systemic diseases and infectious diseases; (2) Have used probiotic products or antibiotics within 2 months; (3) Low birth weight and premature children: birth weight less than 2500 g or delivery earlier than 37 weeks; (4) Patients who are allergic to the components in the test sample or control sample; (5) Those whose compliance cannot meet the requirements or do not sign an informed consent form; (6) Any other circumstances that the researcher deems unsuitable for participation in the study, such as mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of food allergies;Serum IgE and IL-4;Fecal microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Faecal metabolites;Serum IgG, IL-6 and TNF-a; | — |
Countries
China
Contacts
Public ContactMin Lin
Jiangxi Provincial Children’s Hospital
Outcome results
None listed