RecruitingNot ApplicableNCT06569797

Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants

The Effect of Adding Milk Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on the Growth and Development of Infants Aged 0-1 Years: a Multicenter, Double-blind, Randomized, Controlled Trial


Sponsor

Heilongjiang Feihe Dairy Co. Ltd.

Enrollment

240 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.


Eligibility

Min Age: 0 DaysMax Age: 28 Days

Inclusion Criteria5

  • -28 days after birth;
  • Single birth;
  • The gestational age is between 37 and 42 weeks;
  • Birth weight ranges from 2500 to 4000 grams;
  • Parents or guardians agree not to allow infants to participate in other interventional clinical studies during the study period

Exclusion Criteria9

  • Artificial assisted reproduction;
  • The mother suffers from a disease that may endanger intrauterine growth;
  • The mother suffers from pregnancy diabetes or serious metabolic disease or chronic disease during pregnancy
  • Suffering from congenital malformations and genetic diseases, chronic diseases, and congenital diseases that may interfere with the investigation;
  • Suffering from IgE mediated milk protein allergy, or having factors that increase the risk of milk protein allergy;
  • Suffering from acute infection or gastroenteritis;
  • Suffering from functional gastrointestinal diseases, such as gastroparesis;
  • Currently participating in other clinical trials;
  • Researchers cannot determine whether parents have the willingness or ability to comply with the requirements of the protocol.

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Interventions

DIETARY_SUPPLEMENToligosaccharides and multiple nutrients

The effect of adding milk oligosaccharides and optimizing multiple nutrients to infant formula on the growth and development of infants aged 0-1 years

DIETARY_SUPPLEMENTno oligosaccharides and optimizing multiple nutrients

The effect of traditional infant formula milk powder optimized without adding milk oligosaccharides and multiple nutrients on the growth and development of infants aged 0-1 years old.

DIETARY_SUPPLEMENTbreastfeeding

The impact of breastfeeding on the growth and development of infants aged 0-1 years old.


Locations(1)

The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, China

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NCT06569797


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