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

Phase 4

Completed

• Conditions: Intestinal Absorption
• Interventions: Dietary Supplement: Oral consumption of breast milk; Dietary Supplement: Oral consumption of Nutricia Aptamil Stage 1 formula; Dietary Supplement: Oral consumption of a2® Platinum Stage 1 formula

• Registration Number: NCT03081936
• Lead Sponsor: a2 Milk Company Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Study First Submitted: 2016-11-01
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-10
• Last Update Submitted: 2017-03-10
• Study First Posted: 2017-03-17
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast feeding	Oral consumption of breast milk	Oral consumption of breast milk
A1 formula	Oral consumption of Nutricia Aptamil Stage 1 formula	Oral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk)
A2 formula	Oral consumption of a2® Platinum Stage 1 formula	Oral consumption of a2® Platinum Stage 1 formula (containing 100% A2® beta -casein)

Primary Outcome Measures

Name	Time	Method
Stool frequency	Baseline, Week 8	Change from Baseline weekly average of the number of defecation per day at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Fecal microflora counts	Baseline, Day 7, Day 56	Bifidobacterium, Lactobacillus, Clostridium perfringens
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
Stool consistency	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8	Weekly average score of stool consistency
Fecal sIgA concentration	Baseline, Day 7, Day 56
Body weight	Baseline, Day 7, Day 56	Body weight (unit: g)
Body height	Baseline, Day 7, Day 56	Body height (unit: cm)
Head circumstance	Baseline, Day 7, Day 56	Head circumstance (unit: cm)
Chest circumstance	Baseline, Day 7, Day 56	Chest circumstance (unit: cm)
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
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