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Comparative Effects of a2 Platinum Stage 1 Infant Formula on Infant Digestion and Comfort

Healthy Infants Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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". ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04733937
Study type Interventional
Source a2 Milk Company Ltd.
Contact
Status Completed
Phase N/A
Start date December 4, 2020
Completion date April 16, 2022
View Details
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