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Completed

NCT Number: NCT02363582

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

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.

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Key information

Conditions

Infant Formula Intolerance

Age range

5 week–7 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xin Hua Hospital

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula

Other

An infant formula contains prebiotics and lactoferrin

Primary outcomes

  1. growth

    Time frame: 6 weeks

    Head circumferences and weight gain

Secondary outcomes

  1. Gastrointestinal tolerance and safety

    Time frame: 6 weeks

    daily records of vomiting and stool characteristics; records of infection episodes and other adverse effects

  2. intestinal microbiota

    Time frame: 6 weeks

    test the bacteria composition in baby stools by DNA sequencing technology

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2015
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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