The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula). 75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months. Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.
This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Approximately 75 partipants of 30 days old will be enrolled from a study site, 50 of whom will be randomized 1:1 to receive an mask labelled investigational formula or a control formula for 3 months of feeding. The remaining approximately 25 partipants will be enrolled as a breastfeeding reference group. Parents will be instructed to exclusively feed the study formula (formula groups) or exclusively human milk (breastfeeding group) during the study. The study will consist of 4 study visits, on baseline day, and every 30 days. At each visit, all relevant clinical data of partipants will be captured and recorded into CTMS (Clinical Trial Management System). The data will be exported, analyzed and reported upon the study completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
75
Participants in this arm need to be fed the assigned infant formula daily for three months, no other formula or breast milk
Participants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk
Participants in this arm need to be fed with breast milk daily for three months, no infant formula
Qiu Bin Community Hospital
Jinhua, Zhejiang, China
Change in stool consistency, color and amount
Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months
Time frame: over 3 months
Change rate of baby length
Change rate in mm/day of baby length for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby head circumference
Change rate in mm/day of baby head circumference for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby weight
Change rate in gram/day of baby weight for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Average daily intake of formula
Average daily intake of formula in gram or ml for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Frequency of adverse events
Frequency of adverse events for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
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