Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior||Dietary Supplement: Infant Formula Dietary Supplement: breast milk||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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
100 newborns were just fed with breast milk from after birth to six months age.
Dietary Supplement: breast milk
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02658500
|Contact: LI JUFANG||86 email@example.com|
|Contact: JIANG TIEMIN||86 firstname.lastname@example.org|
|Beijing Ditan Hospital Capital Mendical University||Recruiting|
|Beijing, Beijing, China, 100015|
|Contact: DONG XUEYAN 18910005185 email@example.com|
|Tongzhou Matemal & Child Health Hospital of Beijing||Recruiting|
|Beijing, Beijing, China, 101100|
|Contact: LI JUFANG 18910005178 firstname.lastname@example.org|
|Henan University of Science and Technology||Recruiting|
|Luoyang, Henan, China, 471023|
|Contact: CHEN SHUXING 18237961965 email@example.com|
|Central South University||Recruiting|
|Changsha, Hunan, China, 410083|
|Contact: WANG JIANWU 18073109116 firstname.lastname@example.org|
|Study Director:||CHEN LIJUN||Beijing Sanyuan Foods Co Ltd|