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Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02658500
Recruitment Status : Unknown
Verified January 2016 by Beijing Sanyuan Foods Co Ltd.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Capital Institute of Pediatrics, China
Peking University
Beijing Ditan Hospital
Information provided by (Responsible Party):
Beijing Sanyuan Foods Co Ltd

Brief Summary:
This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage. Depending on the type of feeding the infants were divided into 3 groups with random allocation to one of the formula feeding groups: the group A included 100 infants consuming the formula supplement with superior quality whey protein, the group B -100 infants fed with a standard formula, and the group C -100 infants who were breastfed.

Condition or disease Intervention/treatment Phase
Health Behavior Dietary Supplement: Infant Formula Dietary Supplement: breast milk Not Applicable

Detailed Description:

Throughout the human lifetime, the intestinal microbiota performs vital functions, such as barrier function, metabolic reactions, trophic effects, and maturation of the host's innate and adaptive immune responses. Therefore, the human health depends on the gut health. It is reported that the human gut microbiota of a healthy adult is highly resilient and very stable over time. And before it reaches maturity, the microbiota must develop itself from birth and establish its mutually beneficial cohabitation with the host. However, the early developments of the microbiota in infants are influenced by many factors, such as prenatal parameters, the influence of the mother and her microbiota, and therapies occurring around the time of birth.

Human milk is the sole source of nutrition for infants during the first weeks to months after birth, and has evolved to provide nutrition and immunological protection in the extra-uterine environment into which the infant is born. But when breastfeeding is not possible, human newborns may circumstantially be fed with infant formulas. The difference of feeding mode has been demonstrated to have a strong influence on early gut colonization particularly on the probiotic bacteria. Studies show that breastfed infants have higher counts of Bifidobacteria and Lactobacillus and lower counts of Bacteroides, Clostridium, coccoides group, Staphylococcus, and Enterobacteriaceae as compared with formula-fed infants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Study Start Date : January 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Infant Formula
200 newborns just consume the infant formula from 0-42 days to six months age.
Dietary Supplement: Infant Formula
Other Name: superior quality infant formula

Breast Milk
100 newborns were just fed with breast milk from after birth to six months age.
Dietary Supplement: breast milk

Primary Outcome Measures :
  1. Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing [ Time Frame: up to 8 months ]

    At the age of 1, 2, 3, 6 months, 2 g fecal samples were collected from diapers after defaecation, immediately put into a sterile plastic containers and stored at -20℃ until they were transported (within 24 hours) to the technology center of Beijing Sanyuan Foods Co. Then, each sample was frozen at -80℃ until further processing. The samples were transported on dry ice.

    The analysis methods of fecal samples include high-throughput gene sequencing and quantitative real-time PCR for analysis of Bifidobacterium, Lactobacillus, escherichia coli and Candida fungi etc.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 42 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy term newborns (the mean gestational age in weeks > 36.0) with birth weight ≥2500 g appropriate for gestational age
  • Apgar scores > 7
  • Uncomplicated early course of neonatal period
  • Impossibility of breastfeeding (for infants randomized into the bottle-feeding groups)

Exclusion Criteria:

  • The minimum possibility of breastfeeding (for infants randomized into the bottle-feeding groups)
  • The diagnosis of a significant chronic medical condition including: HIV infection; cancer; bone marrow or organ transplantation; blood product administration within the last 3 mo; bleeding disorder; known congenital malformation or genetic disorder
  • If the parent or legal guardian were unable to read and/or comprehend Chinese
  • If the family moved outside of Beijing during the study period (i.e., would be unavailable for follow-up)

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 identifier (NCT number): NCT02658500

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Contact: LI JUFANG 86 010-56306349
Contact: JIANG TIEMIN 86 010-56306597

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China, Beijing
Beijing Ditan Hospital Capital Mendical University Recruiting
Beijing, Beijing, China, 100015
Contact: DONG XUEYAN    18910005185   
Tongzhou Matemal & Child Health Hospital of Beijing Recruiting
Beijing, Beijing, China, 101100
Contact: LI JUFANG    18910005178   
China, Henan
Henan University of Science and Technology Recruiting
Luoyang, Henan, China, 471023
Contact: CHEN SHUXING    18237961965   
China, Hunan
Central South University Recruiting
Changsha, Hunan, China, 410083
Contact: WANG JIANWU    18073109116   
Sponsors and Collaborators
Beijing Sanyuan Foods Co Ltd
Capital Institute of Pediatrics, China
Peking University
Beijing Ditan Hospital
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Study Director: CHEN LIJUN Beijing Sanyuan Foods Co Ltd

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Responsible Party: Beijing Sanyuan Foods Co Ltd Identifier: NCT02658500    
Other Study ID Numbers: D14110000481400
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Beijing Sanyuan Foods Co Ltd:
early infant feeding
infant intestinal flora
infant health