Clinical trial NCT06569797: Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Milk oligosaccharides
multiple nutrients
infants
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 240
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, double-blind, randomized, controlled trial
Primary purpose: BASIC_SCIENCE

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 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.

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 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

Eligibility criteria: 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.

Primary outcomes:
measure: Intestinal indicators
timeFrame: day 28,180,360
measure: Intestinal indicators
timeFrame: day 28,180,360
Secondary outcomes:
measure: Inflammatory markers
timeFrame: day 180,360
measure: Nutritional indicators
timeFrame: day 180,360
measure: Immune indicators
timeFrame: day 28,180,360
measure: Immune indicators
timeFrame: day 180,360
measure: Growth and development indicators
timeFrame: day 28,90,180,360
measure: Growth and development indicators
timeFrame: day 28,90,180,360
measure: Growth and development indicators
timeFrame: day 28,90,180,360
measure: Growth and development indicators
timeFrame: day 28,90,180,360
measure: Bone development indicators
timeFrame: day 180,360
measure: Bone development indicators
timeFrame: day 180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Tolerance indicators
timeFrame: day 28,90,180,360
measure: Cognitive Development
timeFrame: day 28,90,180,360
measure: Cognitive Development
timeFrame: day 180,360
Other outcomes:
measure: adverse event
timeFrame: 1 year
measure: Serious adverse events
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army
state: Beijing
Study officials:
affiliation: Nanjing Medical University
name: Xu Z Wang, doctor
role: STUDY_CHAIR
References: