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

Shanghai Jiao Tong University

Status

Completed

Conditions

Infant Formula Intolerance

Treatments

Other: formula

Study type

Interventional

Funder types

Other

Identifiers

NCT02363582

SCMCIRB-K2013005

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

5 to 7 weeks old

Volunteers

No Healthy Volunteers

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