None
Conditions
Interventions
Group A: Experimental group:Probiotics, 6-12 months old
Group C: Experimental group:Probiotics, for 12-36 months, excluding 12-month-olds
Group D: Control group :Placebo, 12-36 months, excluding 12-month-olds
Group B: Control group:Placebo, 6-12 months
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 6 to 36 months old; 2. Gestational age ranging from 37 to 42 weeks; 3. Birth weight between 2500 and 4000 grams; 4. The mothers of the infants have no diagnosed metabolic diseases such as diabetes, nor any infectious diseases like hepatitis B or HIV; 5. Good compliance, able to follow the clinical trial requirements and regulations; 6. The subjects or their guardians have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Infants with birth defects or congenital abnormalities; 2.Infants with severe malnutrition or delayed growth and development; 3.Infants using antibiotics, antidiarrheal drugs, probiotics, or added probiotic products within 4 weeks prior to randomization; 4.Mothers of breastfed infants who used antibiotics within 4 weeks prior to randomization; 5.Infants with severe diarrhea or more severe and complex diarrhea symptoms, such as ulcerative or blood stasis stools; 6.Infants with serious heart, liver, kidney, hematopoietic system or metabolic hereditary diseases; 7.Infants with organic gastrointestinal diseases (inflammatory bowel disease, abdominal disease, gastrointestinal infections, gastrointestinal tumors, etc.); 8.Infants are allergic or intolerant to the ingredients of experimental probiotic products; 9.Babies have food allergies (such as milk, eggs, etc.); 10.Parents with a history of alcohol and drug abuse; 11.Infants who participated in other clinical trials within the first six months of randomization; 12.Other reasons why researchers believe it is not appropriate to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in gut microbiota (16s rRNA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions and concomitant medications;Blood routine;Allergy related: incidence of respiratory allergies and skin allergies;Functional gastrointestinal diseases (Rome IV, bloating, nausea, reflux, etc.);Fecal immune index (sIgA);Dietary Scale;Disease and infection investigation: fever, frequency of medical treatment;Frequency and duration of diarrhea occurrence;Blood immune and inflammatory markers (CRP, IL-2, IL-6, TNF - a);Height, weight, head circumference;Frequency and duration of constipation occurrence;Fecal Form Scale (BSFS) - frequency of bowel movements; | — |
Countries
China
Contacts
Public ContactSun Zhiping
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed