Well-being Clinical Trial
Official title:
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer
infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual
nutrients as compared to breast-milk in term Chinese infants.
Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.
Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random
allocation between the two infant formula.
Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2)
JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase
I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random
allocation performed between the two formula groups.
Intervention Duration: 12 weeks.
Visits: 1 week(baseline), 7 and 13 weeks of age
Outcome measures: (1) General information, general health and wellbeing, regular body
check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3)
Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and
habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids,
minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes
from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool
characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and
habit index were be calculated.
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