Infant nutrition
Conditions
Interventions
HMOs group:0-4 months: artificial feeding not less than 2 times a day
4-12 months: artificial feeding not less than 5 times a day.
Control group:0-4 months: artificial feeding not less than 2 times a day
Breastfeeding group (BF group):0-4 months: exclusive breastfeeding (must be exclusively breastfed 1 day before the visit)
4 to 12 months: breastfeed at least once a day.
Sponsors
Nanjing Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 0.1 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the breastfeeding group: 1. 0-28 days after birth; 2. Single birth; 3. Gestational age is 36-40 weeks; 4. Birth weight of 2500 ~ 4000 g; 5. The parent or guardian agrees not to allow the infant to participate in other clinical studies during the study period; 6. The parent or guardian consents to the feeding of the infant in accordance with the experimental protocol. Inclusion criteria for the artificial feeding group: 1. 0-28 days after birth; 2. Single birth; 3. Gestational age is 36-40 weeks; 4. Birth weight of 2500 ~ 4000 g; 5. The parent or guardian agrees not to allow the infant to participate in other clinical studies during the study period; 6. Consent of the parent or guardian to the feeding of the infant in accordance with the experimental protocol; 7. For subjective and objective reasons, mothers cannot exclusively breastfeed.
Exclusion criteria
Exclusion criteria: 1. Artificial assisted reproduction; 2. The mother has a disease that may endanger intrauterine growth; 3. The mother had gestational diabetes mellitus or other metabolic diseases or chronic diseases at the time of pregnancy; 4. Congenital malformations and genetic, chronic or congenital diseases that may interfere with the investigation; 5. Have IGE-mediated milk protein allergy, or have factors that increase the risk of milk protein allergy; 6. Acute infection or gastroenteritis; 7. Have a functional gastrointestinal disorder, such as gastroparesis; 8. Participating in other clinical trials; 9. Researchers were unable to determine whether parents had the willingness or ability to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16S rRNA sequencing;short-chain fatty acid (SCFAs); | — |
Secondary
| Measure | Time frame |
|---|---|
| sIgA;total fatty acids;Calcium (Ca);high sensitivity C reactive protein (hsCRP);interleukin-1a (IL-1a);interleukin-1ß (IL-1ß);interleukin-2 (IL-2);interleukin-4 (IL-4);interleukin-8 (IL-8);osteocalcin;alkaline phosphatase (ALP);albumin (Alb);Bayley Infant Development Scale (IV);Feeding status and intake questionnaire;Gastrointestinal comfort questionnaire;Sleeping and crying questionnaire;Diarrhoea and upper respiratory infections questionnaire;Bristol stool classification;chest circumference; | — |
Countries
China
Contacts
Public ContactZhixu Wang
Nanjing Medical University
Outcome results
None listed