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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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Sun Yat-sen University
Guangzhou, Guangdong, China
Start Date
April 10, 2022
Primary Completion Date
December 25, 2023
Completion Date
December 25, 2023
Last Updated
December 27, 2024
179
ACTUAL participants
Breast milk
OTHER
Kieember Infant formula, Ruibuen®
OTHER
Yashili Infant formula, Ruibuen®
OTHER
Lead Sponsor
Sun Yat-sen University
NCT05868408
NCT04919265
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