NCT03178474

Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants

Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 5 Days – 14 Days
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infant Formula Intolerance
• Well-being

Interventions

Type	Name	Description
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
OTHER	TOFER Infant formula,TOFER®	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
OTHER	Breast milk	Breast milk: Human breast milk, provided and fed by the corresponding infant's mother

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-06-30
• Completion: 2017-12-30
• First posted: 2017-06-07
• Last updated: 2017-09-18

Locations

3 sites across 1 country: China