Comparative Effects of A2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort

Summary

This trial is a single-blind, randomized, controlled, parallel-designed trial to compare the effects of a2 Platinum® stage 1 infant formula versus conventional, A1 and A2 β-casein-containing stage 1 infant formula versus breastfeeding on crying, tolerance, gut health, and immune function.

Conditions

• Healthy Infants

Interventions

OTHER

a2 Platinum® stage 1 infant formula

Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.

OTHER

Conventional, A1 and A2 β-casein containing stage 1 infant formula

Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Edanz Group Japan Ltd

  collaborator UNKNOWN

• Women & Children's Health Care Hospital of Linyi, China

  collaborator UNKNOWN

• Beijing Esmile Technology Co. Ltd.

  collaborator UNKNOWN

• Nanjing Maternity and Child Health Care Hospital

  collaborator OTHER

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• a2 Milk Company Ltd.

  lead INDUSTRY

Principal Investigators

• Jiangqin Liu, MD · Shanghai First Maternity and Infant Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

76 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-07

Primary Completion

2022-04-16

Completion

2022-04-16

Countries

• China

Study Locations