Comparative A1 vs A2 Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effects of A1 Versus A2®Cow Milk Based Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant: a Pilot Double-blinded, Randomized, Controlled Parallel Study

Conditions
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Intestinal Absorption

Intervention / Treatment
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* Dietary Supplement: Oral consumption of Nutricia Aptamil Stage 1 formula
* Dietary Supplement: Oral consumption of a2® Platinum Stage 1 formula
* Dietary Supplement: Oral consumption of breast milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to formula feeding and consume 600ml or more of IF each day; Have normal electrocardiograms (ECG) and blood pressure during quiet respiration. Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk; Parent(s) or legal guardian's consent to the study and willing to comply with study procedures; Parent(s) or guardian of infant agrees not to enroll infant another clinical study while participating in this study; Fully understand the nature, objective, benefit and the potential risks and side effects of the study. Exclusion Criteria: Twins, multiple birth, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks; During pregnancy, the mothers had pregnancy complications or other disease that may affect the results; Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other disease; Having neonatal diarrhea or acute respiratory infections within 48hours before enrollment; Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results; Having taken any food containing prebiotics or probiotics tithing 15 days of enrollment; Body weight-to-height Z-value <-3 according to the standard of the World Health Organization (WHO); Receiving hormone therapy and intravenous nutrition; Lactose intolerance or allergic to ingredients of study product; Have history of faecal impaction; Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening; Currently taking medicines for cardiovascular or metabolic disease ; Currently suffering from any gastrointestinal disorders or gastrointestinal disease , including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS); Had hospitalizations within 3 months before screening; According to investigator's judgment, current frequent users of drugs which may affect the gastrointestinal function or immune system; Unable to comply the study schedule.

Ages Eligible for Study
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Minimum Age: 40 Days
Maximum Age: 60 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1 formula<br>Oral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk) | Dietary Supplement: Oral consumption of Nutricia Aptamil Stage 1 formula<br>* Daily oral consumption of Nutricia Aptamil Stage 1 formula<br>|
| Experimental: A2 formula<br>Oral consumption of a2® Platinum Stage 1 formula (containing 100% A2® beta -casein) | Dietary Supplement: Oral consumption of a2® Platinum Stage 1 formula<br>* Daily oral consumption of a2® Platinum Stage 1 formula<br>|
| Active Comparator: Breast feeding<br>Oral consumption of breast milk | Dietary Supplement: Oral consumption of breast milk<br>* Daily oral consumption of breast milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency | Change from Baseline weekly average of the number of defecation per day at 8 weeks | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |