Effects of Breast Milk Simulated Infant Formula

Effects of Breast Milk Simulated Infant Formula: A 3-month Randomized Controlled Trial

Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months.

Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.

Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).

Intervention Duration: 90 days.

Visits: 1month and 3month old.

Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.

Study Overview

• Status: Completed
• Conditions: Breast Milk; Infant Formula
• Intervention / Treatment: Other: Breast milk; Other: Kieember Infant formula, Ruibuen®; Other: Yashili Infant formula, Ruibuen®

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Term infant: Born at 37-42 gestation weeks
• Birth weight: 2500-4000g (appropriate for gestational age)
• The infant is in good health and Apgar after 5 minutes >7
• The mother had unequivocally decided not to breastfeed (for formula fed infants) or to breastfeed (for human milk fed infants)
• age at the enrollment: less than 30 days

Exclusion Criteria:

• The mother is unable to take care of her infant on account of health condition (psychological or physical) or socioeconomic problems
• The infant is born with a congenital malformation or chromosome abnormality with a clinical significance
• The infant suffers from a disease requiring mechanical ventilation or medication in the first week of life (not including applying phototherapy of blue to cure neonatal jaundice)
• The infant whose feeding or normal metabolism is affected by any suspected or unknown metabolic factors or physical limitations
• The infant has been breastfed for more than 2 weeks (for formula fed infants)
• Twins or multiple births

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breast Milk-Fed Group; The infants will be breastfed during the study.	Other: Breast milk; Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
Experimental: Breast Milk Simulated Formula Group; Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.	Other: Kieember Infant formula, Ruibuen®; Kieember Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by (1) OPO structured lipid of the third generation; and (2) Breast Milk Simulated complete structured lipid UPU. It was produced by Yashili New Zealand Dairy Co., Limited
Experimental: Traditional Formula Group; Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.	Other: Yashili Infant formula, Ruibuen®; Yashili Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by(1) lactoferrin and(2) lutein . It was produced by Yashili International Holdings Ltd.,China

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month	Slope of change at 1 and 3 month in gut microbiota pattern score from 16S RNA sequencing.	1,3 months
Average Change Rate of Fecal Residual Fatty Acid from 1month to 3 month	Slope of change at 1 and 3 month in Fecal Residual Fatty Acid.	1,3 months
Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month	Slope of change at 1 and 3 month in Fecal Residual Nitrogen.	1,3 months
Average Change Rate of Fecal Residual Calcium from 1month to 3 month	Slope of change at 1 and 3 month in fecal residual calcium.	1,3 months
Average Change Rate of body length from 1month to 3 month	Slope of change at 1 and 3 month in body length.	1,3 months
Average Change Rate of body weight from 1month to 3 month	Slope of change at 1 and 3 month in body weigh.	1,3 months
Average Change Rate of head circumferences from 1month to 3 month	Slope of change at 1 and 3 month in head circumferences.	1,3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change Rate of Stool Characteristic Index from 1month to 3 month	Slope of change at 1 and 3 month in Stool Characteristic Index: calculated by using stool color (using sample pictures), stool shape (using sample pictures), and frequency.	1,3 months
Average Change Rate of an Index of General health and wellbeing from 1month to 3 month	Slope of change at 1 and 3 month in Index of General health and wellbeing, calculated from diseases (cold, diarrhea,infectious diseases), doctor visits, concomitant medications,etc.	1,3 months
Average Change Rate of Temperament Score from 1month to 3 month	Slope of change at 1 and 3 month in Temperament Score assessed by the Early Infant Temperament Scale	1,3 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: March 13, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: gut microbiota; body growth; temperament; fecal residual nutrient
• Other Study ID Numbers: MN-2022-01

Drug and device information, study documents

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