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This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk based formula on alimentation and gastrointestinal digestion. The impact of the study products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and infant growth were also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 formula | Active Comparator | Oral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk) |
|
| A2 formula | Experimental | Oral consumption of a2® Platinum Stage 1 formula (containing 100% A2® beta -casein) |
|
| Breast feeding | Active Comparator | Oral consumption of breast milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral consumption of Nutricia Aptamil Stage 1 formula | Dietary Supplement | Daily oral consumption of Nutricia Aptamil Stage 1 formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Change from Baseline weekly average of the number of defecation per day at 8 weeks | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency | Weekly average score of stool consistency | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 |
| Stool color | Weekly average score of stool color |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Zhang, MD | Sprim (Shanghai) Consulting Co., Ltd. | Study Director |
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| Oral consumption of a2® Platinum Stage 1 formula | Dietary Supplement | Daily oral consumption of a2® Platinum Stage 1 formula |
|
| Oral consumption of breast milk | Dietary Supplement | Daily oral consumption of breast milk |
|
| Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 |
| Fecal Myeloperoxidase (MPO) concentration | Baseline, Day 7, Day 56 |
| Fecal Short Chain Fatty Acid (SCFA) concentration | Acetic Acid , Propanoic Acid, Butanoic Acid, Total SCFA | Baseline, Day 7, Day 56 |
| Fecal sIgA concentration | Baseline, Day 7, Day 56 |
| Fecal microflora counts | Bifidobacterium, Lactobacillus, Clostridium perfringens | Baseline, Day 7, Day 56 |
| Body weight | Body weight (unit: g) | Baseline, Day 7, Day 56 |
| Body height | Body height (unit: cm) | Baseline, Day 7, Day 56 |
| Head circumstance | Head circumstance (unit: cm) | Baseline, Day 7, Day 56 |
| Chest circumstance | Chest circumstance (unit: cm) | Baseline, Day 7, Day 56 |
| Cry frequency | Weekly average of cry frequency per day | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 |
| Cry duration | Weekly average of cumulative cry duration per day | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 |
| Sleep duration | Weekly average of cumulative sleep duration per day | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 |
| Milk regurgitation frequency | Weekly average of milk regurgitation frequency per day | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 |
| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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