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

Not Applicable

Completed

• Conditions: Infant Formula Intolerance

• Registration Number: NCT02363582
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-01-31
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-16
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
growth	6 weeks	Head circumferences and weight gain

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xin Hua Hospital; 🇨🇳 Shanghai, Shanghai, China