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

Not Applicable

• Conditions: Health Behavior
• Interventions: Dietary Supplement: Infant Formula; Dietary Supplement: breast milk

• Registration Number: NCT02658500
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Last Update Submitted: 2016-01-14
• Study First Posted: 2016-01-20
• Last Update Posted: 2016-01-20
• Primary Completion: 2016-06
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Formula	Infant Formula	200 newborns just consume the infant formula from 0-42 days to six months age.
Breast Milk	breast milk	100 newborns were just fed with breast milk from after birth to six months age.

Primary Outcome Measures

Name	Time	Method
Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing	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.

Trial Locations

Locations (4)

Beijing Ditan Hospital Capital Mendical University; 🇨🇳 Beijing, Beijing, China

Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Central South University; 🇨🇳 Changsha, Hunan, China

Tongzhou Matemal & Child Health Hospital of Beijing; 🇨🇳 Beijing, Beijing, China