Completed
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
What is being tested
Oral consumption of Nutricia Aptamil Stage 1 formula
+ Oral consumption of a2® Platinum Stage 1 formula
+ Oral consumption of breast milk
Dietary Supplement
Who is being recruted
+22 Eligibility Criteria
How is the trial designed
Supportive Care Study
Phase 4
Interventional
Study Start: November 2015
Summary
Principal Sponsora2 Milk Company Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2015
Actual date on which the first participant was enrolled.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 TitleComparative 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
Principal Sponsora2 Milk Company Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Range of ages for which participants are eligible to join.
Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
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;
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16 exclusion criteria prevent from participating
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;
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorOral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk)
Group II
ExperimentalOral consumption of a2® Platinum Stage 1 formula (containing 100% A2® beta -casein)
Group III
Active ComparatorOral consumption of breast milk
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers