Allergy prevention, intestinal health
Conditions
Interventions
Placebo group:Once daily, 3 drops (placebo, 0 CFU/ drop). The intervention began on the day of randomization and was continuously supplemented for 90 days.
Probiotic group:Receive Bifidobacterium longum subspecies dipro-F intervention once daily, 3 drops each time (1×10^9 CFU/3 drops). The intervention began on the day of randomization and was continuous
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Probiotic group (1) Healthy infants and young children aged 0 to 36 months at the time of enrollment, with a gestational age of 37 to 42 weeks, a birth weight of 2500g to 4000g, regardless of gender, who are fed with pure formula milk and/or mixed feeding. (2) According to the scoring criteria, they are identified as high-risk groups; (3) No allergic diseases were diagnosed by clinical doctors at the time of enrollment; (4) The legal guardian agrees to participate in this study and signs a written informed consent. 2. Placebo group (1) Healthy infants and young children aged 0 to 36 months at the time of enrollment, with a gestational age of 37 to 42 weeks, a birth weight of 2500g to 4000g, regardless of gender, who are fed with pure formula milk and/or mixed feeding. (2) According to the scoring criteria, they are identified as high-risk groups; (3) No allergic diseases were diagnosed by clinical doctors at the time of enrollment; (4) The legal guardian agrees to participate in this study and signs a written informed consent. 3. Healthy control group (1) Healthy infants and young children aged 0 to 36 months at the time of enrollment, with a gestational age of 37 to 42 weeks, a birth weight of 2500g to 4000g, regardless of gender, who are fed with pure formula milk and/or mixed feeding. (2) According to the scoring criteria, it is determined to be a low-risk group; (3) No allergic diseases were diagnosed by clinical doctors at the time of enrollment; (4) The legal guardian agrees to participate in this study and signs a written informed consent. 4. Blank control group (1) Healthy infants aged 0 to 6 months at the time of enrollment, with a gestational age of 37 to 42 weeks and a birth weight of 2500g to 4000g, regardless of gender, who are only breastfed; (2) According to the scoring criteria, they are identified as high-risk groups; (3) No allergic diseases were diagnosed by clinical doctors at the time of enrollment; (4) The legal guardian agrees to participate in this study and signs a written informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject’s mother has a history of metabolic diseases or infectious diseases, including but not limited to diabetes mellitus, hepatitis B, HIV infection, or other major infectious diseases; 2. The subject’s mother had high-risk pregnancy conditions during gestation, including hypertensive disorders of pregnancy, preeclampsia or eclampsia, gestational diabetes mellitus, intrahepatic cholestasis of pregnancy, or a history of alcohol abuse, drug abuse, or other substance abuse; 3. Use of antibiotics within 4 weeks prior to enrollment; 4. Use of probiotic products within 4 weeks prior to enrollment (for infants aged <1 month at enrollment, this refers to the period from birth to enrollment); 5. Receipt of immunosuppressive medication (e.g., glucocorticoids or other immunosuppressants) prior to enrollment; 6. Presence of acute or chronic diseases that have a clear impact on infant growth and development within 4 weeks prior to enrollment; 7. Presence of congenital malformations or birth defects; 8. Presence of malnutrition requiring hospitalization; 9. Known allergy to any component of the investigational probiotic product; 10. Participation in other clinical trials or use of any investigational drugs within 3 months prior to enrollment screening (for infants aged <3 months at enrollment, this refers to the period from birth to enrollment); 11. Any factors that, in the investigator’s opinion, may affect safety or the interpretation of study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptom assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Intestinal flora;Nutritional assessment;Adverse event; | — |
Countries
China
Contacts
Public ContactZhang Jinping
Shanghai Sixth People’s Hospital
Outcome results
None listed