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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
33
Daily oral consumption of Nutricia Aptamil Stage 1 formula
Daily oral consumption of a2® Platinum Stage 1 formula
Daily oral consumption of breast milk
Stool frequency
Change from Baseline weekly average of the number of defecation per day at 8 weeks
Time frame: Baseline, Week 8
Stool consistency
Weekly average score of stool consistency
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Stool color
Weekly average score of stool color
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Fecal Myeloperoxidase (MPO) concentration
Time frame: Baseline, Day 7, Day 56
Fecal Short Chain Fatty Acid (SCFA) concentration
Acetic Acid , Propanoic Acid, Butanoic Acid, Total SCFA
Time frame: Baseline, Day 7, Day 56
Fecal sIgA concentration
Time frame: Baseline, Day 7, Day 56
Fecal microflora counts
Bifidobacterium, Lactobacillus, Clostridium perfringens
Time frame: Baseline, Day 7, Day 56
Body weight
Body weight (unit: g)
Time frame: Baseline, Day 7, Day 56
Body height
Body height (unit: cm)
Time frame: Baseline, Day 7, Day 56
Head circumstance
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Head circumstance (unit: cm)
Time frame: Baseline, Day 7, Day 56
Chest circumstance
Chest circumstance (unit: cm)
Time frame: Baseline, Day 7, Day 56
Cry frequency
Weekly average of cry frequency per day
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Cry duration
Weekly average of cumulative cry duration per day
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Sleep duration
Weekly average of cumulative sleep duration per day
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Milk regurgitation frequency
Weekly average of milk regurgitation frequency per day
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8