Infectious diseases in children
Conditions
Interventions
HMO intervention group:Once a day, 1 package (containing Bifidobacterium longum infant subspecies R0033 and Bifidobacterium bifidum R0071, 2 '-FL 1.0g), the intervention started from the day of use of
Probiotic intervention group:Once a day, 1 package (containing Bifidobacterium longum infant subspecies R0033 and Bifidobacterium bifidum R0071), the intervention started from the day of use of the
Placebo control group:Once a day, 1 package (containing only maltodextrin), the intervention started from the day of use of the product, and the follow-up was 3 months after 3 months of continuous sup
Sponsors
Baoxing County Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
1 Years to 3 Years
Inclusion criteria
Inclusion criteria: ? 3 years old = full age when enrolled = 1 year old; ? Full term birth at 37 to 42 weeks and birth weight greater than 2500 g and less than 4000g, without sex restriction; ? Formula milk powder was fed from birth to enrollment or have stopped breastfeeding for 3 months; ? Parents voluntarily chose to feed their children with pre-packaged pure milk/fresh milk without probiotics and/or prebiotics at the time of enrollment; ? The child's parent or primary guardian agrees to collect stool and saliva samples during the study period; ? No allergic diseases diagnosed by clinicians at the time of enrollment (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.); ? Register in the child care department of the local maternal and child health hospital and receive regular physical examinations and feeding advice and guidance from the child health doctor; ? The family or primary guardian commits not to add additional probiotic products (including formula, yogurt, etc., containing probiotics and/or prebiotics) to the infant during the intervention period. ? The guardian of enrolled subjects agrees to participate in the intervention study and signs a written informed consent, and can understand and fill in the infant diary and other forms as required.
Exclusion criteria
Exclusion criteria: ?The infant has a history of birth asphyxia or NICU hospitalization; ?The child has a birth defect or congenital abnormality, such as severe congenital heart disease, epilepsy, cerebral palsy, mental retardation and other neurological diseases, as well as exact genetic metabolic diseases, chromosome diseases, genetic diseases; ?The infants had used antibiotics within 2 weeks before enrollment; ?Diseases that definitely affect the growth and development of infants (such as pneumonia, severe diarrhea, severe constipation, severe milk protein allergy, malnutrition, gastrointestinal surgery, etc., neurological diseases such as severe congenital heart disease, epilepsy, cerebral palsy, mental retardation, and exact inherited metabolic diseases, chromosomal diseases, genetic diseases, etc.) 1 month before enrollment; ?Complicated with serious primary diseases of other vital organs or systems such as heart, liver, kidney and hematopoietic system; ?Prior to screening, use of experimental drugs after birth, participation in other clinical studies; ?Infants took probiotics or prebiotics related products one month before enrollment; ?Infants who had used immunosuppressive drugs (such as glucocorticoids and immunosuppressants) before enrollment; ?Infants allergic to known milk protein, lactose, probiotic product ingredients; ?first-degree relatives of infants with confirmed allergic diseases; ?Other reasons that the investigator deems inappropriate to participate in the clinical trial, such as influencing efficacy evaluation or poor adherence; ?infants were diagnosed with recurrent respiratory infection prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Allergic diseases incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Growth and development;Infant infectious incidence;Intestinal health status of infants (occurrence of functional gastrointestinal diseases such as diarrhea and constipation and functional dyspepsia syndrome);Changes in the diversity and abundance of intestinal flora;FUT2 genotyping; | — |
Countries
China
Contacts
Public ContactChen Ke
Baoxing County Center for Disease Control and Prevention
Outcome results
None listed