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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
180
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.
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.
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Second Hospital of Jilin University
Changchun, Jilin, China
Women & Children's Health Care Hospital of Linyi, China
Linyi, Shandong, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
Changes of crying frequency at each follow up visit compared to baseline
Record frequency of crying (times/d)
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Changes of crying duration at each follow up visit compared to baseline
Record duration of crying (min)
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in fecal MPO levels at each follow up visit compared to baseline
Record fecal MPO (in Unit) as markers of inflammation
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in salivary cortisol levels at each follow up visit compared to baseline
Record salivary cortisol (nmol/L) as markers of immune function
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in body length
Differences in length gain (cm/d)
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)
Changes in body weight
Differences in weight gain (kg/d)
Time frame: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Changes in head circumference
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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Differences in head circumference (cm/d)
Time frame: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Number of adverse events at each follow up visit compared to baseline
Record number of adverse events as a measure of safety and tolerability
Time frame: Visit 1 (screening/randomization); Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 day after baseline); Visit 4 (28 days after baseline)
Abundance analysis of gut microflora species
Differences in abundance of gut microflora species
Time frame: Visit 2 (baseline [90-105 days since birth]); Visit 3 (14 days after baseline); Visit 4 (28 days after baseline)