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

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ClinicalTrials.gov Identifier: NCT03178474
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yu-ming Chen, Sun Yat-sen University

Brief 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.


Condition or disease Intervention/treatment Phase
Infant Formula Intolerance Well-being Other: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH® Other: TOFER Infant formula,TOFER® Other: Breast milk Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Researchers involved in laboratory tests will be blinded to the group status
Primary Purpose: Prevention
Official Title: Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Breast-Fed Group
The infants will be fed with human breast milk by their mother
Other: Breast milk
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.
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

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.
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Other Outcome Measures:
  1. 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

  2. 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



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178474


Contacts
Contact: Yuming Chen, Ph.D. 8613710230430 chenyum@mail.sysu.edu.cn
Contact: Qian Zhou 862087330726 zhouq83@mail.sysu.edu.cn

Locations
China, Henan
Lankao Hospital Terminated
Kaifeng, Henan, China
China, Hunan
Shaoyang Center Hospital Recruiting
Shaoyang, Hunan, China
Contact: Ding Ding         
China
Nanxiong Hospital Terminated
Shaoguan, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Yuming Chen, Ph.D. Sun Yat-sen University

Responsible Party: Yu-ming Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03178474     History of Changes
Other Study ID Numbers: Yili_trial01
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yu-ming Chen, Sun Yat-sen University:
infant formula
Clinical trial
Chinese infant
body growth
gut microbiota
Stool characteristics