NCT04733937

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

Protocol Title: Comparative Effects of A2 Platinum® Stage 1 Infant Formula Versus Conventional Stage 1 Infant Formula Containing A1 and A2 Β-casein Versus Breast Feeding on Infant Digestion and Comfort: a Single-blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: a2 Milk Company Ltd. · Industry
• Sex: All
• Age: 0 Days – 76 Days
• Healthy volunteers: Accepted

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.

Detailed description

The protocol was updated from V8.2 to V9.1 and was approved by the Ethical Committee of Shanghai First Maternity and Infant Hospital, the main site. The major changes are: from "blind to participants" to "non-blind to participants"; from "Single-Centre" to "Multi-Centre"; number of subjects from "270" to "180"; trial period from "3 weeks" to "4 weeks"; and number of visits from "6" to "4".

Conditions

• Healthy Infants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-04-16
• Completion: 2022-04-16
• First posted: 2021-02-02
• Last updated: 2024-10-18

Locations

5 sites across 1 country: China