Effects of Breast Milk Simulated Infant Formula

Sun Yat-sen University

Status: Completed

Conditions: Breast Milk; Infant Formula

Treatments: Other: Breast milk; Other: Kieember Infant formula, Ruibuen®; Other: Yashili Infant formula, Ruibuen®

Study type: Interventional

Funder types: Other

Identifiers

NCT05295030

MN-2022-01

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: Under 30 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 3 patient groups

Breast Milk-Fed Group

Active Comparator group

Description:

The infants will be breastfed during the study.

Treatment:

Other: Breast milk

Breast Milk Simulated Formula Group

Experimental group

Description:

Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.

Treatment:

Other: Kieember Infant formula, Ruibuen®

Traditional Formula Group

Experimental group

Description:

Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.

Treatment:

Other: Yashili Infant formula, Ruibuen®