The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Formula Intolerance
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- growth
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Jiang WU
MD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
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
Outcomes
Primary Outcomes
growth
Time Frame: 6 weeks
Head circumferences and weight gain
Secondary Outcomes
- Gastrointestinal tolerance and safety(6 weeks)
- intestinal microbiota(6 weeks)