Completed

The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

What is being tested

a2 Platinum Premium Infant Formula Stage 1

+ Frisolac Infant Formula Stage 1 (Dutch Edition)

Dietary Supplement

Who is being recruted

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: July 2023

See protocol details

Summary

Principal Sponsora2 Milk Company Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 14, 2023

Actual date on which the first participant was enrolled.

This study focuses on comparing the effects of a2 infant formula with traditional A1/A2 infant formula on the growth of healthy term infants. The main goal is to see if there are differences in how infants grow when fed these different formulas. This research is important as it may reveal if a2 formula offers any advantages in terms of growth or other health benefits over the conventional formula. The study also looks at how these formulas affect skin conditions like dermatitis, how well infants tolerate and accept the formulas, and any medically confirmed issues that might arise from using them. Participants in this study attend four visits over 56 days, with assessments on day 0, day 14, day 28, and day 56. During these visits, researchers collect information about the infants' growth and other health outcomes. Parents keep a diary to note how well their child tolerates the formula and how much they consume daily. At the end of the study, parents also share their satisfaction with the formula. This structured approach helps ensure comprehensive data collection to assess the safety and effectiveness of the a2 infant formula.

Official TitleThe Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

NCT06256094

Principal Sponsora2 Milk Company Ltd.

Last updated: January 28, 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

280 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

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

Healthy and term infants (37-42 weeks gestation);

Birth weight between 2500g and 4500g;

60-120 days of age after birth;

Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;

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7 exclusion criteria prevent from participating

Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;

Evidence of feeding difficulties or intolerance/allergy to cow's milk;

Conditions requiring infant feedings other than those specified in the protocol;

Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other) or parental refusal to participate;

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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

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

a2 Platinum Premium Stage 1 (0-6 months) cow's milk based powder infant formula

Group II

Active Comparator

Dutch Edition of the Frisolac Stage 1 (0-6 months) cow's milk based powder infant formula

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 1 location

Suspended

Shanghai Weierkang Pediatric Outpatient Department

Shanghai, ChinaOpen Shanghai Weierkang Pediatric Outpatient Department in Google Maps

CompletedOne Study Center