Status:
RECRUITING
Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants
Lead Sponsor:
Heilongjiang Feihe Dairy Co. Ltd.
Conditions:
Healthy
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief 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...
Detailed Description
In this clinical trial, the effects of adding oligosaccharides to breast milk and optimizing multiple nutrients in infant formula, conventional infant formula, and breast milk on the growth and develo...
Eligibility Criteria
Inclusion
- 0-28 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
- 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.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06569797
Start Date
January 8 2024
End Date
September 30 2025
Last Update
August 26 2024
Active Locations (1)
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1
The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, China, 100000