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

NCT03178474 | Unknown

• 1 other identifier: Yili_trial01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Infant Formula Intolerance; Well-being

Keywords

infant formula; Clinical trial; Chinese infant; body growth; gut microbiota; Stool characteristics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks

  0, 6, 12 weeks

• Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks

  0, 6, 12 weeks

• Average Change Rate of body length from Baseline to 6 and 12 weeks

  0, 6, 12 weeks

• Average Change Rate of Body Weight from Baseline to 6 and 12 weeks

  0, 6, 12 weeks

• Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks

  0, 6, 12 weeks

Other Outcomes (2)

• Average Change Rate of Fecal Residual Iron from Baseline at 6 and 12 weeks

  0, 6, 12 weeks

• Average Change Rate of Fecal Residual Zinc from Baseline at 6 and 12 weeks

  0, 6, 12 weeks

Study Arms (3)

Breast-Fed Group

ACTIVE COMPARATOR

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

Other: Breast milk

TOFER Formula Group

EXPERIMENTAL

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®

JINLINGGUAN Formula Group

EXPERIMENTAL

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®

Interventions

JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH® OTHER

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

JINLINGGUAN Formula Group

TOFER Infant formula,TOFER® OTHER

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

TOFER Formula Group

Breast milk OTHER

Breast milk: Human breast milk, provided and fed by the corresponding infant's mother

Breast-Fed Group

Eligibility Criteria

• Age: 5 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (3)

Lankao Hospital

Kaifeng, Henan, China

TERMINATED

Shaoyang Center Hospital

Shaoyang, Hunan, China

RECRUITING

Nanxiong Hospital

Shaoguan, China

TERMINATED

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Yuming Chen, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Chen, Ph.D.

CONTACT

8613710230430; chenyum@mail.sysu.edu.cn

Qian Zhou

CONTACT

862087330726; zhouq83@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers involved in laboratory tests will be blinded to the group status
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 7, 2017
• Study Start: December 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: December 30, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)