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

Sun Yat-sen University

Status: Unknown

Conditions: Well-being; Infant Formula Intolerance

Treatments: Other: TOFER Infant formula,TOFER®; Other: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®; Other: Breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT03178474

Yili_trial01

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 5 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Breast-Fed Group

Active Comparator group

Description:

The infants will be fed with human breast milk by their mother

Treatment:

Other: Breast milk

TOFER Formula Group

Experimental group

Description:

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.

Treatment:

Other: TOFER Infant formula,TOFER®

JINLINGGUAN Formula Group

Experimental group

Description:

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.

Treatment:

Other: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®