Children Allergic Disease
Conditions
Interventions
Probiotic intervention group:Once a day, 1 packet (containing Lactobacillus rhamnosus LRa05 strain 1.5×1010 CFU/ packet), the course of treatment starts from the day of use of probiotic products, and
Placebo control group:Once a day, 1 packet (maltodextrin, without Lactobacillus rhamnosus LRa05 strain), the course of treatment starts from the day of use of probiotic products, and continues to supp
Breastfeeding control group:No intervention measures were implemented
only breastfeeding was provided.
Sponsors
Chengdu Women and Children's Central Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the exclusive breastfeeding group: 1. Healthy infants and toddlers born at term (37-42 weeks of gestation) who are exclusively breastfed, with a birth weight of at least 2500g but less than 4000g, and no gender restrictions; 2. The mother has no diagnosed metabolic diseases such as diabetes, and no infectious diseases such as hepatitis B or HIV; 3. The age at inclusion is less than 7 months; 4. The parents or main guardians of the infants and toddlers agree to collect fecal samples from the infants and toddlers during the study period; 5. There are no diagnosed allergic diseases by a clinical physician at the time of inclusion (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.); 6. The infants and toddlers have established a health record at the local maternal and child health hospital's pediatric health department and receive regular physical examinations and feeding advice and guidance from pediatric health doctors; 7. The family members or main guardians promise not to add any additional probiotic products (including formula milk powder containing probiotics) to the infants and toddlers during the study period; 8. The guardians of the included subjects agree to participate in this interventional study and sign a written informed consent form, and are able to understand and fill out the infant and toddler diaries and other forms as required. Inclusion criteria for the formula feeding group: 1. Healthy infants and toddlers born at term (37-42 weeks of gestation) who are formula-fed, with a birth weight of at least 2500g but less than 4000g, and no gender restrictions; 2. The mother has no diagnosed metabolic diseases such as diabetes, and no infectious diseases such as hepatitis B or HIV; 3. The age at inclusion is 0-6 months, 7-12 months, or 13-36 months; 4. The parents or main guardians of the infants and toddlers agree to collect fecal samples from the infants and toddlers during the study period; 5. There are no diagnosed allergic diseases by a clinical physician at the time of inclusion (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.); 6. The infants and toddlers have established a health record at the local maternal and child health hospital's pediatric health department and receive regular physical examinations and feeding advice and guidance from pediatric health doctors; 7. The family members or main guardians promise not to add any additional probiotic products (including formula milk powder containing probiotics) to the infants and toddlers during the study period; 8. The guardians of the included subjects agree to participate in this interventional study and sign a written informed consent form, and are able to understand and fill out the infant and toddler diaries and other forms as required.
Exclusion criteria
Exclusion criteria: Exclusive breastfeeding control group: 1. Infants and young children with a history of asphyxia at birth or a history of NICU hospitalization; 2. Infants and young children with birth defects or congenital abnormalities; 3. Infants and young children whose mothers had high-risk obstetric factors during pregnancy, such as pregnancy-induced hypertension syndrome, preeclampsia and eclampsia, gestational diabetes, and cholestasis of pregnancy, as well as a history of alcohol abuse or drug abuse; 4. Infants and young children who had used antibiotics within two weeks before enrollment; 5. Infants and young children who had diseases that definitely affected growth and development within one month before enrollment (such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, etc., severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as definite genetic metabolic diseases, chromosomal diseases, and genetic diseases); 6. Infants and young children with severe primary diseases of important organs or systems such as the heart, liver, kidneys, and hematopoietic system; 7. Infants and young children who had used any experimental drugs or participated in other clinical studies within three months before screening (for infants and young children under 3 months of age, the time from birth to enrollment is calculated); 8. Infants and young children who had taken probiotic products within one month before enrollment (for infants and young children under 1 month of age, the time from birth to enrollment is calculated); 9. Infants and young children who had used drugs that suppressed immune function (such as glucocorticoids and immunosuppressants) before enrollment; Infants and young children who were allergic to the known components of the probiotic product; 10. Infants and young children who were allergic to the known components of the probiotic product; 11. Children with malnutrition requiring hospitalization; 12. Other reasons considered by the researcher as unsuitable for participation in this clinical trial, such as those that affect the evaluation of efficacy or have poor compliance. Healthy infants and young children aged 0-6 months: 1. Infants and young children with a history of asphyxia at birth or a history of NICU hospitalization; 2. Infants and young children with birth defects or congenital abnormalities; 3. Infants and young children whose mothers had high-risk obstetric factors during pregnancy, such as pregnancy-induced hypertension syndrome, preeclampsia and eclampsia, gestational diabetes, and intrahepatic cholestasis of pregnancy, as well as a history of alcohol abuse or drug abuse; 4. Infants and young children who had used antibiotics within 2 weeks before enrollment; 5. Infants and young children who had diseases that definitely affected growth and development within 1 month before enrollment (such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, etc., severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as definite genetic metabolic diseases, chromosomal diseases, and genetic diseases); 6. Infants and young children with severe primary diseases of important organs or systems such as the heart, liver, kidneys, and hematopoietic system; 7. Infants and you
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of allergy in infants; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal health status of infants (occurrence of functional gastrointestinal diseases such as diarrhea and constipation and functional dyspepsia syndrome);Incidence of upper respiratory tract infections in infants and young children (including frequency, duration, intensity, and medication);Changes in the diversity and abundance of intestinal flora;Growth and development; | — |
Countries
China
Contacts
Public ContactChen Ke
Chengdu Women and Children's Central Hospital
Outcome results
None listed