Intestinal Absorption
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOral consumption of Nutricia Aptamil Stage 1 formula
Daily oral consumption of Nutricia Aptamil Stage 1 formula
DIETARY_SUPPLEMENTOral consumption of a2® Platinum Stage 1 formula
Daily oral consumption of a2® Platinum Stage 1 formula
DIETARY_SUPPLEMENTOral consumption of breast milk
Daily oral consumption of breast milk
Sponsors
a2 Milk Company Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Days to 60 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency | Baseline, Week 8 | Change from Baseline weekly average of the number of defecation per day at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool color | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Weekly average score of stool color |
| Fecal Myeloperoxidase (MPO) concentration | Baseline, Day 7, Day 56 | — |
| Fecal Short Chain Fatty Acid (SCFA) concentration | Baseline, Day 7, Day 56 | Acetic Acid , Propanoic Acid, Butanoic Acid, Total SCFA |
| Fecal sIgA concentration | Baseline, Day 7, Day 56 | — |
| Fecal microflora counts | Baseline, Day 7, Day 56 | Bifidobacterium, Lactobacillus, Clostridium perfringens |
| Body weight | Baseline, Day 7, Day 56 | Body weight (unit: g) |
| Stool consistency | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Weekly average score of stool consistency |
| Head circumstance | Baseline, Day 7, Day 56 | Head circumstance (unit: cm) |
| Chest circumstance | Baseline, Day 7, Day 56 | Chest circumstance (unit: cm) |
| Cry frequency | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Weekly average of cry frequency per day |
| Cry duration | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Weekly average of cumulative cry duration per day |
| Sleep duration | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Weekly average of cumulative sleep duration per day |
| Milk regurgitation frequency | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Weekly average of milk regurgitation frequency per day |
| Body height | Baseline, Day 7, Day 56 | Body height (unit: cm) |
Outcome results
None listed