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

NCT ID: NCT02363582

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-07-31

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.

Conditions

Infant Formula Intolerance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Breast fed

healthy term infants on exclusively breast feeding , enrollment age: 30-50days old

Group Type: NO_INTERVENTION

No interventions assigned to this group

Formula fed

healthy term infants on exclusively formula fed , enrollment age: 30-50days old

Group Type: EXPERIMENTAL

formula

Intervention Type: OTHER

An infant formula contains prebiotics and lactoferrin

Interventions

formula

An infant formula contains prebiotics and lactoferrin

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Weeks
• Maximum Eligible Age: 7 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiang WU

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital

Locations

Xin Hua Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SCMCIRB-K2013005

Identifier Type: -

Identifier Source: org_study_id