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The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.
In this clinical trial, the effects of adding oligosaccharides to breast milk and optimizing multiple nutrients in infant formula, conventional infant formula, and breast milk on the growth and development of infants under 1 year old were evaluated by comparing the intestinal indicators (16s rRNA, SCFAs), inflammatory indicators, nutritional indicators, immune indicators, growth and development indicators, bone development indicators, tolerance indicators, cognitive development, adverse events, and serious adverse events of 80 experimental groups, 80 control groups, and 80 breastfeeding groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Feeding infant formula with added milk oligosaccharides and optimized for multiple nutrients |
|
| control group | Active Comparator | Feeding with regular infant formula milk powder |
|
| Breastfeeding group | Active Comparator | Breastfeeding with breast milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oligosaccharides and multiple nutrients | Dietary Supplement | The effect of adding milk oligosaccharides and optimizing multiple nutrients to infant formula on the growth and development of infants aged 0-1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal indicators | 16s rRNA | day 28,180,360 |
| Intestinal indicators | SCFAs | day 28,180,360 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | serum hsCRP | day 180,360 |
| Nutritional indicators | serum albumin | day 180,360 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | adverse event | 1 year |
| Serious adverse events | Serious adverse events | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao W Su, Master | Contact | +8613413399214 | +8613413399214 | suwuhao@esmile.com.cn |
| Wei Q Zhang, Bachelor | Contact | +8615500023637 | +8615500023637 | zhangqiwei@esmile.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xu Z Wang, doctor | Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2023 | Aug 11, 2024 |
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multicenter, double-blind, randomized, controlled trial
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This clinical study is a double-blind trial, and before unblinding, neither the researchers nor the subjects know whether they belong to the experimental group or the control group
| no oligosaccharides and optimizing multiple nutrients | Dietary Supplement | The effect of traditional infant formula milk powder optimized without adding milk oligosaccharides and multiple nutrients on the growth and development of infants aged 0-1 years old. |
|
| breastfeeding | Dietary Supplement | The impact of breastfeeding on the growth and development of infants aged 0-1 years old. |
|
| Immune indicators | fecal sIgA | day 28,180,360 |
| Immune indicators | blood lymphocyte subsets | day 180,360 |
| Growth and development indicators | height | day 28,90,180,360 |
| Growth and development indicators | weight | day 28,90,180,360 |
| Growth and development indicators | head circumference | day 28,90,180,360 |
| Growth and development indicators | chest circumference | day 28,90,180,360 |
| Bone development indicators | osteocalcin | day 180,360 |
| Bone development indicators | alkaline phosphatase | day 180,360 |
| Tolerance indicators | investigation of infant gastrointestinal comfort：In the past week, the average daily number of reflux .The minimum number is 0, and there is no limit to the maximum number. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant gastrointestinal comfort：In the past week, abdominal pain VAS score of the infant.The minimum score is 0, and the maximum score is 10. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant sleep crying：In the past week, the average daily crying time.The minimum time is 0 hours and the maximum time is 24 hours. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant sleep crying：In the past week, the average daily crying frequency.The minimum number of times is 0, and the maximum number of times is unlimited. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant sleep crying：In the past week, the average daily crying severity. The severity of crying is divided into no crying, mild crying, moderate crying, very crying, and extreme crying. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant sleep crying：In the past week, the average daily crying daytime and nighttime sleep duration. The minimum time is 0 hours and the maximum time is 12 hours. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant sleep crying：In the past week, sleep problems of infants.Sleep problems are divided into no problem, minor problem, moderate problem, major problem, and extreme problem. | day 28,90,180,360 |
| Tolerance indicators | investigation of infant diarrhea and upper respiratory tract infections：The severity of diarrhea and upper respiratory tract infections (colds) in infants from birth until now. The severity level is classified as no problem, minor problem, moderate problem, major problem, and maximum problem. | day 28,90,180,360 |
| Tolerance indicators | Bristol stool classification of infant feces | day 28,90,180,360 |
| Cognitive Development | Bailey Infant Development Scale (Version IV) Score（130 or above, very excellent; 120-129, excellent; 110~119, upper middle; 90-109, moderate; 80-89, below average; 70-79, critical state; Below 69, developmental delay） | day 28,90,180,360 |
| Cognitive Development | Serum Amino Acids | day 180,360 |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D007774 | Lactation |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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