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

September 14, 2017 updated by: Yu-ming Chen, Sun Yat-sen University

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

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 days to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yuming Chen, Ph.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 30, 2017

Study Completion (Anticipated)

December 30, 2017

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 3, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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