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

Infant Formula Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363582
• Other study ID #: SCMCIRB-K2013005
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2015
• Last updated: February 9, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Jiang Wu, MD
• Phone: 86 21 25078999
• Email: eureka_wz[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Weeks to 7 Weeks

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infant Formula Intolerance

Intervention

Other:
• formula
An infant formula contains prebiotics and lactoferrin

Locations

Country	Name	City	State
China	Xin Hua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	growth	Head circumferences and weight gain	6 weeks	No
Secondary	Gastrointestinal tolerance and safety	daily records of vomiting and stool characteristics; records of infection episodes and other adverse effects	6 weeks	Yes
Secondary	intestinal microbiota	test the bacteria composition in baby stools by DNA sequencing technology	6 weeks	No