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

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ClinicalTrials.gov Identifier: NCT02363582
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jiang WU, 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.

Condition or disease Intervention/treatment Phase
Infant Formula Intolerance Other: formula Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Breast fed
healthy term infants on exclusively breast feeding , enrollment age: 30-50days old
Experimental: Formula fed
healthy term infants on exclusively formula fed , enrollment age: 30-50days old
Other: formula
An infant formula contains prebiotics and lactoferrin




Primary Outcome Measures :
  1. growth [ Time Frame: 6 weeks ]
    Head circumferences and weight gain


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   5 Weeks to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363582


Locations
China, Shanghai
Xin Hua Hospital
Shanghai, Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jiang Wu, MD Xin Hua Hospital

Responsible Party: Jiang WU, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02363582     History of Changes
Other Study ID Numbers: SCMCIRB-K2013005
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lactoferrin
Anti-Infective Agents