Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
NCT ID: NCT03178474
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2015-12-01
2017-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Breast-Fed Group
The infants will be fed with human breast milk by their mother
Breast milk
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
TOFER Formula Group
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.
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
JINLINGGUAN Formula Group
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.
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
Interventions
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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®
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
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
Eligibility Criteria
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Inclusion Criteria
* Term infant of Chinese origin born at 37-42 gestation weeks
* Birth weight: 2500-4000g
* The infant is apparently healthy at birth and entry to study
* Apgar after 5 minutes \>7
* age at the enrollment: 5-14 days
Exclusion Criteria
* The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth
* The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth (not including photo treatment for infantile hepatitis)
* The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism
5 Days
14 Days
ALL
Yes
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yu-ming Chen
Professor
Principal Investigators
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Yuming Chen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Lankao Hospital
Kaifeng, Henan, China
Shaoyang Center Hospital
Shaoyang, Hunan, China
Nanxiong Hospital
Shaoguan, , China
Countries
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Central Contacts
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Facility Contacts
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Ding Ding
Role: primary
Other Identifiers
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Yili_trial01
Identifier Type: -
Identifier Source: org_study_id