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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04733937
Other study ID # A2MC-G190549140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2020
Est. completion date April 16, 2022

Study information

Verified date November 2022
Source a2 Milk Company Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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".


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Study Design


Related Conditions & MeSH terms


Intervention

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.
Conventional, A1 and A2 ß-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.

Locations

Country Name City State
China Second Hospital of Jilin University Changchun Jilin
China Women & Children's Health Care Hospital of Linyi, China Linyi Shandong
China Nanjing Maternity and Child Health Care Hospital Nanjing Jiangsu
China Shanghai First Maternity and Infant Hospital Shanghai Shanghai
China First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin Tianjin

Sponsors (9)

Lead Sponsor Collaborator
a2 Milk Company Ltd. Beijing Esmile Technology Co. Ltd., Edanz Group Japan Ltd, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Nanjing Maternity and Child Health Care Hospital, Second Hospital of Jilin University, Shanghai First Maternity and Infant Hospital, Women & Children's Health Care Hospital of Linyi, China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of crying frequency at each follow up visit compared to baseline Record frequency of crying (times/d) Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Primary Changes of crying duration at each follow up visit compared to baseline Record duration of crying (min) Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Primary Changes in fecal MPO levels at each follow up visit compared to baseline Record fecal MPO (in Unit) as markers of inflammation Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Secondary Changes in salivary cortisol levels at each follow up visit compared to baseline Record salivary cortisol (nmol/L) as markers of immune function Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Secondary Changes in body length Differences in length gain (cm/d) Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Secondary Changes in body weight Differences in weight gain (kg/d) Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Secondary Changes in head circumference Differences in head circumference (cm/d) Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Secondary Number of adverse events at each follow up visit compared to baseline Record number of adverse events as a measure of safety and tolerability Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Secondary Abundance analysis of gut microflora species Differences in abundance of gut microflora species Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
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