The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants

Conditions
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Infant Formula Intolerance

Intervention / Treatment
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* Other: formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Weeks
Maximum Age: 7 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breast fed<br>healthy term infants on exclusively breast feeding , enrollment age: 30-50days old | |
| Experimental: Formula fed<br>healthy term infants on exclusively formula fed , enrollment age: 30-50days old | Other: formula<br>* An infant formula contains prebiotics and lactoferrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth | Head circumferences and weight gain | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance and safety | daily records of vomiting and stool characteristics; records of infection episodes and other adverse effects | 6 weeks | 
| intestinal microbiota | test the bacteria composition in baby stools by DNA sequencing technology | 6 weeks |