Effects of Breast Milk Simulated Infant Formula

Breast Milk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295030
• Other study ID #: MN-2022-01
• Status: Completed
• Phase: N/A
• Start date: April 10, 2022
• Est. completion date: December 25, 2023

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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：150 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: December 25, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk
• Infant Formula

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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