Clinical trial NCT03178474: Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
Official title: Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Formula Intolerance
Well-being
Keywords: infant formula
Clinical trial
Chinese infant
body growth
gut microbiota
Stool characteristics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 180
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Fecal Residual Nitrogen from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Fecal Residual Fat from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Fecal Residual Calcium from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
Secondary outcomes:
measure: Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of body length from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Body Weight from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Gut Microbiota Pattern Score from Baseline at 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Pattern Score of Fecal Residual Fatty acids from Baseline at 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
Other outcomes:
measure: Average Change Rate of Fecal Residual Iron from Baseline at 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
measure: Average Change Rate of Fecal Residual Zinc from Baseline at 6 and 12 weeks
timeFrame: 0, 6, 12 weeks
Locations:
city: Kaifeng
country: China
facility: Lankao Hospital
state: Henan
city: Shaoyang
country: China
facility: Shaoyang Center Hospital
state: Hunan
city: Shaoguan
country: China
facility: Nanxiong Hospital
Study officials:
affiliation: Sun Yat-sen University
name: Yuming Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: