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 range
0 Days – 30 Days
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Average Change Rate of Gut Microbiota Pattern Score from 1month to 3 month
Timeframe: 1,3 months
Average Change Rate of Fecal Residual Fatty Acid from 1month to 3 month
Timeframe: 1,3 months
Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month
Timeframe: 1,3 months
Average Change Rate of Fecal Residual Calcium from 1month to 3 month
Timeframe: 1,3 months
Average Change Rate of body length from 1month to 3 month
Timeframe: 1,3 months
Average Change Rate of body weight from 1month to 3 month
Timeframe: 1,3 months
Average Change Rate of head circumferences from 1month to 3 month
Timeframe: 1,3 months