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

NCT06569797 | Recruiting

• 1 other identifier: Nan Yi Da Lun (2023) No. 524
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Milk oligosaccharides; multiple nutrients; infants

Outcome Measures

Primary Outcomes (2)

• Intestinal indicators

  16s rRNA

  day 28,180,360

• Intestinal indicators

  SCFAs

  day 28,180,360

Secondary Outcomes (21)

• Inflammatory markers

  day 180,360

• Nutritional indicators

  day 180,360

• Immune indicators

  day 28,180,360

• Immune indicators

  day 180,360

• Growth and development indicators

  day 28,90,180,360

Other Outcomes (2)

• adverse event

  1 year

• Serious adverse events

  1 year

Study Arms (3)

experimental group

EXPERIMENTAL

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

Dietary Supplement: oligosaccharides and multiple nutrients

control group

ACTIVE COMPARATOR

Feeding with regular infant formula milk powder

Dietary Supplement: no oligosaccharides and optimizing multiple nutrients

Breastfeeding group

ACTIVE COMPARATOR

Breastfeeding with breast milk

Dietary Supplement: breastfeeding

Interventions

oligosaccharides and multiple nutrients DIETARY_SUPPLEMENT

The effect of adding milk oligosaccharides and optimizing multiple nutrients to infant formula on the growth and development of infants aged 0-1 years

experimental group

no oligosaccharides and optimizing multiple nutrients DIETARY_SUPPLEMENT

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.

control group

breastfeeding DIETARY_SUPPLEMENT

The impact of breastfeeding on the growth and development of infants aged 0-1 years old.

Breastfeeding group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.: lead

Study Sites (1)

The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

Oligosaccharides; Lactation

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Xu Z Wang, doctor

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Hao W Su, Master

CONTACT

+8613413399214; suwuhao@esmile.com.cn

Wei Q Zhang, Bachelor

CONTACT

+8615500023637; zhangqiwei@esmile.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical study is a double-blind trial, and before unblinding, neither the researchers nor the subjects know whether they belong to the experimental group or the control group
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, double-blind, randomized, controlled trial

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 26, 2024
• Study Start: January 8, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)