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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: oligosaccharides and multiple nutrients; Dietary supplement: no oligosaccharides and optimizing multiple nutrients; Dietary supplement: breastfeeding

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

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao W Su, Master; Phone Number: +8613413399214 +8613413399214; Email: suwuhao@esmile.com.cn
• Study Contact Backup: Name: Wei Q Zhang, Bachelor; Phone Number: +8615500023637 +8615500023637; Email: zhangqiwei@esmile.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Feeding infant formula with added milk oligosaccharides and optimized for multiple nutrients	Dietary supplement: oligosaccharides 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
Active Comparator: control group; Feeding with regular infant formula milk powder	Dietary supplement: no 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.
Active Comparator: Breastfeeding group; Breastfeeding with breast milk	Dietary supplement: breastfeeding; The impact of breastfeeding on the growth and development of infants aged 0-1 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal indicators	16s rRNA	day 28,180,360
Intestinal indicators	SCFAs	day 28,180,360

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	serum hsCRP	day 180,360
Nutritional indicators	serum albumin	day 180,360
Immune indicators	fecal sIgA	day 28,180,360
Immune indicators	blood lymphocyte subsets	day 180,360
Growth and development indicators	height	day 28,90,180,360
Growth and development indicators	weight	day 28,90,180,360
Growth and development indicators	head circumference	day 28,90,180,360
Growth and development indicators	chest circumference	day 28,90,180,360
Bone development indicators	osteocalcin	day 180,360
Bone development indicators	alkaline phosphatase	day 180,360
Tolerance indicators	investigation of infant gastrointestinal comfort：In the past week, the average daily number of reflux .The minimum number is 0, and there is no limit to the maximum number.	day 28,90,180,360
Tolerance indicators	investigation of infant gastrointestinal comfort：In the past week, abdominal pain VAS score of the infant.The minimum score is 0, and the maximum score is 10.	day 28,90,180,360
Tolerance indicators	investigation of infant sleep crying：In the past week, the average daily crying time.The minimum time is 0 hours and the maximum time is 24 hours.	day 28,90,180,360
Tolerance indicators	investigation of infant sleep crying：In the past week, the average daily crying frequency.The minimum number of times is 0, and the maximum number of times is unlimited.	day 28,90,180,360
Tolerance indicators	investigation of infant sleep crying：In the past week, the average daily crying severity. The severity of crying is divided into no crying, mild crying, moderate crying, very crying, and extreme crying.	day 28,90,180,360
Tolerance indicators	investigation of infant sleep crying：In the past week, the average daily crying daytime and nighttime sleep duration. The minimum time is 0 hours and the maximum time is 12 hours.	day 28,90,180,360
Tolerance indicators	investigation of infant sleep crying：In the past week, sleep problems of infants.Sleep problems are divided into no problem, minor problem, moderate problem, major problem, and extreme problem.	day 28,90,180,360
Tolerance indicators	investigation of infant diarrhea and upper respiratory tract infections：The severity of diarrhea and upper respiratory tract infections (colds) in infants from birth until now. The severity level is classified as no problem, minor problem, moderate problem, major problem, and maximum problem.	day 28,90,180,360
Tolerance indicators	Bristol stool classification of infant feces	day 28,90,180,360
Cognitive Development	Bailey Infant Development Scale (Version IV) Score（130 or above, very excellent; 120-129, excellent; 110~119, upper middle; 90-109, moderate; 80-89, below average; 70-79, critical state; Below 69, developmental delay）	day 28,90,180,360
Cognitive Development	Serum Amino Acids	day 180,360

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event	adverse event	1 year
Serious adverse events	Serious adverse events	1 year

Collaborators and Investigators

• Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
• Investigators: Study Chair: Xu Z Wang, doctor, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: infants; Milk oligosaccharides; multiple nutrients
• Other Study ID Numbers: Nan Yi Da Lun (2023) No. 524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No