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

China Feihe

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: no oligosaccharides and optimizing multiple nutrients; Dietary Supplement: breastfeeding; Dietary Supplement: oligosaccharides and multiple nutrients

Study type: Interventional

Funder types: Industry

Identifiers

NCT06569797

Nan Yi Da Lun (2023) No. 524

Details and patient eligibility

About

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.

Full 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 development of infants under 1 year old were evaluated by comparing the intestinal indicators (16s rRNA, SCFAs), inflammatory indicators, nutritional indicators, immune indicators, growth and development indicators, bone development indicators, tolerance indicators, cognitive development, adverse events, and serious adverse events of 80 experimental groups, 80 control groups, and 80 breastfeeding groups

Enrollment: 240 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 3 patient groups

experimental group

Experimental group

Description:

Feeding infant formula with added milk oligosaccharides and optimized for multiple nutrients

Treatment:

Dietary Supplement: oligosaccharides and multiple nutrients

control group

Active Comparator group

Description:

Feeding with regular infant formula milk powder

Treatment:

Dietary Supplement: no oligosaccharides and optimizing multiple nutrients

Breastfeeding group

Active Comparator group

Description:

Breastfeeding with breast milk

Treatment:

Dietary Supplement: breastfeeding