An interventional study of JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH® and TOFER Infant formula,TOFER® in Infant Formula Intolerance and Well-being, sponsored by Sun Yat-sen University. Status unknown at 3 sites in China. Open to participants aged 5 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention
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.
Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
The infants will be fed with human breast milk by their mother
Other: Breast milk
TOFER Infant formula,TOFER®: Infants will be fed by using TOFER® infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age.
Other: TOFER Infant formula,TOFER®
JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: Infants will be fed by using JINLINGGUAN (PRO-KIDO™ I-PROTECH®) infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age.
Other: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®
JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: a type of Phase I infant formula for 0-6 month infants, with a trademark of PRO-KIDO™ I-PROTECH®. The formula contains both OPO structured lipid and α+β patented protein (patent number: ZL200810241156.3).It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China
TOFER Infant formula,TOFER®: a type of Phase I infant formula for 0-6 month infants, with a trademark of TOFER®. The formula was characterized by (1) Moderate digestible small-molecule protein; and (2) BID® complex probiotics. It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Stool Characteristic Index: calculated using stool color (using sample pictures), volume (small, normal or large using sample picture scale), stool consistency (runny, mushy, soft, formed or hard), and frequency
Time frame: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Nitrogen from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Fecal Residual Nitrogen
Time frame: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Fat from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual total fat
Time frame: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Calcium from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual calcium
Time frame: 0, 6, 12 weeks
Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Index of General health and wellbeing, calculated from diseases (cold, diarrhea, bronchitis, pneumonia), doctor visits, gastro symptoms,etc.
Time frame: 0, 6, 12 weeks
Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Behavior and Habit Score assessed by infant behavior questionnaires
Time frame: 0, 6, 12 weeks
Average Change Rate of body length from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in body length
Time frame: 0, 6, 12 weeks
Average Change Rate of Body Weight from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in body weight
Time frame: 0, 6, 12 weeks
Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in head circumference
Time frame: 0, 6, 12 weeks
Average Change Rate of Gut Microbiota Pattern Score from Baseline at 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in gut microbiota pattern score from 16S RNA sequencing
Time frame: 0, 6, 12 weeks
Average Change Rate of Pattern Score of Fecal Residual Fatty acids from Baseline at 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in the pattern score of fecal residual fatty acids
Time frame: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Iron from Baseline at 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual iron
Time frame: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Zinc from Baseline at 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual zinc
Time frame: 0, 6, 12 weeks
Plan to share: No
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