An interventional study of Breast milk and Kieember Infant formula, Ruibuen® in Infant Formula and Breast Milk, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 0 Days to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Other
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.
Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The infants will be breastfed during the study.
Other: Breast milk
Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.
Other: Kieember Infant formula, Ruibuen®
Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.
Other: Yashili Infant formula, Ruibuen®
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
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®: 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
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.
Time frame: 1,3 months
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.
Time frame: 1,3 months
Average Change Rate of Fecal Residual Nitrogen from 1month to 3 month
Slope of change at 1 and 3 month in Fecal Residual Nitrogen.
Time frame: 1,3 months
Average Change Rate of Fecal Residual Calcium from 1month to 3 month
Slope of change at 1 and 3 month in fecal residual calcium.
Time frame: 1,3 months
Average Change Rate of body length from 1month to 3 month
Slope of change at 1 and 3 month in body length.
Time frame: 1,3 months
Average Change Rate of body weight from 1month to 3 month
Slope of change at 1 and 3 month in body weigh.
Time frame: 1,3 months
Average Change Rate of head circumferences from 1month to 3 month
Slope of change at 1 and 3 month in head circumferences.
Time frame: 1,3 months
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.
Time frame: 1,3 months
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.
Time frame: 1,3 months
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
Time frame: 1,3 months
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University