- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuming Chen, Ph.D.
- Phone Number: 8613710230430
- Email: chenyum@mail.sysu.edu.cn
Study Contact Backup
- Name: Qian Zhou
- Phone Number: 862087330726
- Email: zhouq83@mail.sysu.edu.cn
Study Locations
-
-
-
Shaoguan, China
- Terminated
- Nanxiong Hospital
-
-
Henan
-
Kaifeng, Henan, China
- Terminated
- Lankao Hospital
-
-
Hunan
-
Shaoyang, Hunan, China
- Recruiting
- Shaoyang Center Hospital
-
Contact:
- Ding Ding
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants)
- 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:
- Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Breast-Fed Group
The infants will be fed with human breast milk by their mother
|
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
|
Experimental: 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®: 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
|
Experimental: 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®: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 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
|
0, 6, 12 weeks
|
Average Change Rate of Fecal Residual Nitrogen from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in Fecal Residual Nitrogen
|
0, 6, 12 weeks
|
Average Change Rate of Fecal Residual Fat from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in fecal residual total fat
|
0, 6, 12 weeks
|
Average Change Rate of Fecal Residual Calcium from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in fecal residual calcium
|
0, 6, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 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.
|
0, 6, 12 weeks
|
Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in Behavior and Habit Score assessed by infant behavior questionnaires
|
0, 6, 12 weeks
|
Average Change Rate of body length from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in body length
|
0, 6, 12 weeks
|
Average Change Rate of Body Weight from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in body weight
|
0, 6, 12 weeks
|
Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in head circumference
|
0, 6, 12 weeks
|
Average Change Rate of Gut Microbiota Pattern Score from Baseline at 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in gut microbiota pattern score from 16S RNA sequencing
|
0, 6, 12 weeks
|
Average Change Rate of Pattern Score of Fecal Residual Fatty acids from Baseline at 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in the pattern score of fecal residual fatty acids
|
0, 6, 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Change Rate of Fecal Residual Iron from Baseline at 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in fecal residual iron
|
0, 6, 12 weeks
|
Average Change Rate of Fecal Residual Zinc from Baseline at 6 and 12 weeks
Time Frame: 0, 6, 12 weeks
|
Slope of change at 0, 6 and 12 weeks in fecal residual zinc
|
0, 6, 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yuming Chen, Ph.D., Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Yili_trial01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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