Regulation and Mechanism of New Compound Functional Ingredients in Infants

Regulation and Mechanism of New Compound Functional Ingredients on Intestinal Microecology and Immune Function in Infants

A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age.

Study Overview

• Status: Not yet recruiting
• Conditions: Sialic Acid; Oligosaccharide
• Intervention / Treatment: Dietary supplement: The infants who drank milk powder were given a dietary intervention four months before

Detailed Description

Breast milk is the most beneficial and safe natural food for the growth and development of infants, but some mothers cannot complete breast feeding.For infants who cannot be breastfed, how to improve the composition of formula milk powder and improve the growth and development of infants is an important issue to be solved urgently in this field.It has been found that new compound functional ingredients oligosaccharides and sialic acid may be beneficial to the healthy growth and development of infants and young children, but the specific mechanism and significance are still unclear due to the lack of systematic research.Known as the "second Brain", the gut is connected to the Brain via the brain-gut-axis.Intestinal microecological status can significantly affect the development of infant nervous system and immune system, and then affect the occurrence of related diseases in adulthood.Oligosaccharides and sialic acid may affect the structure of intestinal microecology, protect the immune function of infants and promote the healthy development of infants.This project is based on the previous studies, using multicenter, prospective, randomized, double-blind, parallel-group trial, discussion of oligosaccharides and sialic acid in infants and young children the intestinal micro ecology and the regulation of immune function and the role mechanism, revealing the oligosaccharides and sialic acid in infants and young children the role of immediate and long-term growth, and the significance of these new type of composite function is added to the dairy ingredients, to research and development more accord with our country new dairy products provide theoretical basis for the healthy growth of infants and young children.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Ying T Han; Phone Number: +8613661013288; Email: hanying1568@126.com

Study Locations

• China
  • Beijing, China, 100191
    • Peking University First Hospital
    • Contact: Ying Han, Dr.; Phone Number: +86 13661013288; Email: hanying1568@126.com
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: Yan Xing, Dr.; Phone Number: 13641349699; Email: xingyan770424@vip.sina.com
    • Beijing, Beijing, China, 100191
      • Peking University People's Hospital
      • Contact: Jiong Qin, Dr.; Phone Number: 13701086050; Email: qinjiong@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Breastfeeding group The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition.

Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.

Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.

Description

Inclusion Criteria:

1. Healthy infants;
2. Full-term (gestational age ≥37 weeks);
3. Birth weight 2500-4500g;
4. Mothers have no history of diabetes, hypertension, heart disease, and other diseases during pregnancy;
5. The guardian signed informed consent and voluntarily enrolled into the group and promised to complete systematic follow-up.

Exclusion Criteria:

1. Hospitalization with cognitive impairment or deformity ≥2 days
2. History of birth asphyxia (Apgar score < 3)
3. Severe allergy to milk and serious medical conditions such as intracranial hemorrhage, chronic diarrhea, necrotizing colitis, or acute infection
4. The guardian refused to enroll or could not complete the system follow-up.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastfeeding group; The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition.
Formula group containing new compound functional ingredients; Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.	Dietary supplement: The infants who drank milk powder were given a dietary intervention four months before; The infants who eat milk powder were randomly divided into two groups: group containing new compound functional ingredients and group without new compound functional ingredients
Formula group without new compound functional ingredients; Only use formula milk powder without oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.	Dietary supplement: The infants who drank milk powder were given a dietary intervention four months before; The infants who eat milk powder were randomly divided into two groups: group containing new compound functional ingredients and group without new compound functional ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth and development indexes	Baby body length, weight, head circumference gain	12 months
Growth and development indexes	Baby body weight gain	12 months
Growth and development indexes	Baby body head circumference gain	12 months
Neurodevelopmental level	The Peabody scale was used to assess the level of neural development of infants at 4 months and 6 months	4 months
Neurodevelopmental level	The Peabody scale was used to assess the level of neural development of infants at 6 months	6 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Peking University First Hospital; Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Infant; Human milk; Growth and development; immune level
• Other Study ID Numbers: S170003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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