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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Milk-Fed Group | Active Comparator | The infants will be breastfed during the study. |
|
| Breast Milk Simulated Formula Group | Experimental | Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old. |
|
| Traditional Formula Group | Experimental | Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast milk | Other | Breast milk: Human breast milk, provided and fed by the corresponding infant's mother |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1,3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1,3 months |
| Average Change Rate of an Index of General health and wellbeing from 1month to 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41705972 | Derived | Qiu YZ, Yang MT, Liu Z, Chen XY, Chen JD, Huang SY, Lan QY, Hu Y, Zhou X, Wei W, Wang X, Ye X, Zhu HL. Impact of medium- and long-chain triacylglycerols and sn-2 palmitate on temperament development in term infants: potential role of gut Bifidobacterium. Food Funct. 2026 Mar 9;17(5):2399-2409. doi: 10.1039/d5fo03451e. |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Kieember Infant formula, Ruibuen® | Other | 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® | Other | 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 |
|
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. |
| 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 | 1,3 months |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |