Allergy prevent
Conditions
Interventions
Probiotic group:Receives Bifidobacterium longum subsp. longum dipro-O intervention
Placebo group:Receives placebo intervention
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Group One (1) Healthy Infants And Young Children Aged 0–36 Months At Enrollment, With Gestational Age Of 37–42 Weeks, Birth Weight Of 2500g–4000g, Any Gender, Exclusively Formula-Fed And/Or Mixed-Fed (2) Classified As High-Risk Population Based On Scoring Criteria (3) Not Diagnosed With Any Allergic Diseases By A Clinician At Enrollment (4) Legal Guardians Agree To Participate In This Study And Sign Written Informed Consent 2. Group Two (1) Healthy Infants And Young Children Aged 0–36 Months At Enrollment, With Gestational Age Of 37–42 Weeks, Birth Weight Of 2500g–4000g, Any Gender, Exclusively Formula-Fed And/Or Mixed-Fed (2) Classified As High-Risk Population According To The Scoring Criteria (3) Not Diagnosed With Any Allergic Disease By A Clinician At Enrollment (4) Legal Guardians Agree To Participate In This Study And Sign Written Informed Consent 3. Group Three (1) Healthy Infants And Young Children Aged 0–36 Months At Enrollment, With Gestational Age Of 37–42 Weeks, Birth Weight Of 2500g–4000g, Any Gender, Exclusively Formula-Fed And/Or Mixed-Fed (2) Classified As Low-Risk Population According To The Scoring Criteria (3) Not Diagnosed With Any Allergic Disease By A Clinician At Enrollment (4) Legal Guardians Agree To Participate In This Study And Sign Written Informed Consent 4. Group Four (1) Healthy Infants Aged 0–6 Months At Enrollment, With Gestational Age Of 37–42 Weeks, Birth Weight Of 2500g–4000g, Any Gender, Exclusively Breastfed (2) Classified As High-Risk Population According To The Scoring Criteria (3) Not Diagnosed With Any Allergic Disease By A Clinician At Enrollment (4) Legal Guardians Agree To Participate In This Study And Sign 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 |
|---|---|
| Nutritional assessment;Intestinal flora;Physical examination; | — |
Countries
China
Contacts
Public ContactZhao Mingyi
The Third Xiangya Hospital Central South University
Outcome results
None listed