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

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

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 Overview

• Status: Completed
• Conditions: Intestinal Absorption
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: a2 Milk Company Ltd.
• Investigators: Study Director: Charlie Zhang, MD, Sprim (Shanghai) Consulting Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15-SC-6-A2-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO