Infant Formula Intolerance
Conditions
Brief summary
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.
Detailed description
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora as well as the intestinal immune systems. The purpose of this study is to investigate the stool characteristics（including intestinal microbiota） acceptability, and gastrointestinal tolerance in infants fed a starting infant formula supplemented with prebiotics and lactoferrin, and compared these data with infants on exclusively breast feeding.
Interventions
OTHERformula
An infant formula contains prebiotics and lactoferrin
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Weeks to 7 Weeks
Healthy volunteers
No
Inclusion criteria
* full-term with a birth weight ≥2,500 g * be in good health * without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment * exclusively fed by breast milk or infant formula
Exclusion criteria
* preterm infant * with known diseases or currently taking medication drugs * mixed feeding * with symptoms of diarrhea * received antibiotics within 1 week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| growth | 6 weeks | Head circumferences and weight gain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance and safety | 6 weeks | daily records of vomiting and stool characteristics; records of infection episodes and other adverse effects |
| intestinal microbiota | 6 weeks | test the bacteria composition in baby stools by DNA sequencing technology |
Countries
China
Outcome results
None listed