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

Well-being Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178474
• Other study ID #: Yili_trial01
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2017
• Last updated: September 14, 2017
• Start date: December 1, 2015
• Est. completion date: December 30, 2017

Study information

• Verified date: September 2017
• Source: Sun Yat-sen University
• Contact: Yuming Chen, Ph.D.
• Phone: 8613710230430
• Email: chenyum[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Formula Intolerance
• Well-being

Intervention

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 a+ß 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

Locations

Country	Name	City	State
China	Lankao Hospital	Kaifeng	Henan
China	Nanxiong Hospital	Shaoguan
China	Shaoyang Center Hospital	Shaoyang	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	0, 6, 12 weeks
Other	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	0, 6, 12 weeks
Primary	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	0, 6, 12 weeks
Primary	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	0, 6, 12 weeks
Primary	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	0, 6, 12 weeks
Primary	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	0, 6, 12 weeks
Secondary	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.	0, 6, 12 weeks
Secondary	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	0, 6, 12 weeks
Secondary	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	0, 6, 12 weeks
Secondary	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	0, 6, 12 weeks
Secondary	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	0, 6, 12 weeks
Secondary	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	0, 6, 12 weeks
Secondary	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	0, 6, 12 weeks