NCT05295030

Effects of Breast Milk Simulated Infant Formula

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 0 Days – 30 Days
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2022-04-10
• Primary completion: 2023-12-25
• Completion: 2023-12-25
• First posted: 2022-03-24
• Last updated: 2024-12-27

Locations

1 site across 1 country: China