Effects of Breast Milk Simulated Infant Formula

NCT05295030 | Completed

• 1 other identifier: MN-2022-01
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infant Formula; Breast Milk

Keywords

gut microbiota; temperament; body growth; fecal residual nutrient

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Average Change Rate of Stool Characteristic Index from 1month to 3 month

  1,3 months

• Average Change Rate of an Index of General health and wellbeing from 1month to 3 month

  1,3 months

• Average Change Rate of Temperament Score from 1month to 3 month

  1,3 months

Study Arms (3)

Breast Milk-Fed Group

ACTIVE COMPARATOR

The infants will be breastfed during the study.

Other: Breast milk

Breast Milk Simulated Formula Group

EXPERIMENTAL

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®

Traditional Formula Group

EXPERIMENTAL

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®

Interventions

Breast milk OTHER

Breast milk: Human breast milk, provided and fed by the corresponding infant's mother

Breast Milk-Fed Group

Kieember Infant formula, Ruibuen® OTHER

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

Breast Milk Simulated Formula Group

Yashili Infant formula, Ruibuen® OTHER

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

Traditional Formula Group

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 24, 2022
• Study Start: April 10, 2022
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)