Clinical trial NCT02658500: Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: early infant feeding
infant intestinal flora
infant health
Lead sponsor: Beijing Sanyuan Foods Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Capital Institute of Pediatrics, China
name: Peking University
name: Beijing Ditan Hospital
First posted: 2016-01-20
Enrollment: 300
Sex: ALL
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Mendical University
state: Beijing
city: Beijing
country: China
facility: Tongzhou Matemal & Child Health Hospital of Beijing
state: Beijing
city: Luoyang
country: China
facility: Henan University of Science and Technology
state: Henan
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
affiliation: Beijing Sanyuan Foods Co Ltd
name: CHEN LIJUN
role: STUDY_DIRECTOR
References:
citation: Matamoros S, Gras-Leguen C, Le Vacon F, Potel G, de La Cochetiere MF. Development of intestinal microbiota in infants and its impact on health. Trends Microbiol. 2013 Apr;21(4):167-73. doi: 10.1016/j.tim.2012.12.001. Epub 2013 Jan 14.
citation: Rouge C, Goldenberg O, Ferraris L, Berger B, Rochat F, Legrand A, Gobel UB, Vodovar M, Voyer M, Roze JC, Darmaun D, Piloquet H, Butel MJ, de La Cochetiere MF. Investigation of the intestinal microbiota in preterm infants using different methods. Anaerobe. 2010 Aug;16(4):362-70. doi: 10.1016/j.anaerobe.2010.06.002. Epub 2010 Jun 9.
citation: Ahrne S, Lonnermark E, Wold AE, Aberg N, Hesselmar B, Saalman R, Strannegard IL, Molin G, Adlerberth I. Lactobacilli in the intestinal microbiota of Swedish infants. Microbes Infect. 2005 Aug-Sep;7(11-12):1256-62. doi: 10.1016/j.micinf.2005.04.011. Epub 2005 Jun 8.
citation: Endo A, Pӓrtty A, Kalliomӓki M, Isolauri E, Salminen S. Long-term monitoring of the human intestinal microbiota from the 2nd week to 13 years of age. Anaerobe. 2014 Aug;28:149-56. doi: 10.1016/j.anaerobe.2014.06.006. Epub 2014 Jun 13.
citation: Bisgaard H, Li N, Bonnelykke K, Chawes BL, Skov T, Paludan-Muller G, Stokholm J, Smith B, Krogfelt KA. Reduced diversity of the intestinal microbiota during infancy is associated with increased risk of allergic disease at school age. J Allergy Clin Immunol. 2011 Sep;128(3):646-52.e1-5. doi: 10.1016/j.jaci.2011.04.060. Epub 2011 Jul 22.
citation: Kapiki A, Costalos C, Oikonomidou C, Triantafyllidou A, Loukatou E, Pertrohilou V. The effect of a fructo-oligosaccharide supplemented formula on gut flora of preterm infants. Early Hum Dev. 2007 May;83(5):335-9. doi: 10.1016/j.earlhumdev.2006.07.003. Epub 2006 Sep 14.
citation: Chrzanowska-Liszewska D, Seliga-Siwecka J, Kornacka MK. The effect of Lactobacillus rhamnosus GG supplemented enteral feeding on the microbiotic flora of preterm infants-double blinded randomized control trial. Early Hum Dev. 2012 Jan;88(1):57-60. doi: 10.1016/j.earlhumdev.2011.07.002. Epub 2011 Nov 4.
citation: Arboleya S, Ang L, Margolles A, Yiyuan L, Dongya Z, Liang X, Solis G, Fernandez N, de Los Reyes-Gavilan CG, Gueimonde M. Deep 16S rRNA metagenomics and quantitative PCR analyses of the premature infant fecal microbiota. Anaerobe. 2012 Jun;18(3):378-80. doi: 10.1016/j.anaerobe.2012.04.013. Epub 2012 May 8.
citation: Schwiertz A, Gruhl B, Lobnitz M, Michel P, Radke M, Blaut M. Development of the intestinal bacterial composition in hospitalized preterm infants in comparison with breast-fed, full-term infants. Pediatr Res. 2003 Sep;54(3):393-9. doi: 10.1203/01.PDR.0000078274.74607.7A. Epub 2003 Jun 4.
citation: Fallani M, Young D, Scott J, Norin E, Amarri S, Adam R, Aguilera M, Khanna S, Gil A, Edwards CA, Dore J; Other Members of the INFABIO Team. Intestinal microbiota of 6-week-old infants across Europe: geographic influence beyond delivery mode, breast-feeding, and antibiotics. J Pediatr Gastroenterol Nutr. 2010 Jul;51(1):77-84. doi: 10.1097/MPG.0b013e3181d1b11e.
citation: Andersen BL, Farrar WB, Golden-Kreutz DM, Glaser R, Emery CF, Crespin TR, Shapiro CL, Carson WE 3rd. Psychological, behavioral, and immune changes after a psychological intervention: a clinical trial. J Clin Oncol. 2004 Sep 1;22(17):3570-80. doi: 10.1200/JCO.2004.06.030.
citation: Meropol SB, Edwards A. Development of the infant intestinal microbiome: A bird's eye view of a complex process. Birth Defects Res C Embryo Today. 2015 Dec;105(4):228-39. doi: 10.1002/bdrc.21114. Epub 2015 Dec 11.
citation: Wernimont S, Northington R, Kullen MJ, Yao M, Bettler J. Effect of an alpha-lactalbumin-enriched infant formula supplemented with oligofructose on fecal microbiota, stool characteristics, and hydration status: a randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2015 Apr;54(4):359-70. doi: 10.1177/0009922814553433. Epub 2014 Oct 8.
citation: Qiao W, Chen J, Zhang M, Wang Y, Yang B, Zhao J, Jiang T, Chen L. A cohort study of vitamins contents in human milk from maternal-infant factors. Front Nutr. 2022 Sep 6;9:993066. doi: 10.3389/fnut.2022.993066. eCollection 2022.
citation: Chen J, Liu Y, Zhao J, Jiang T, Xu T, Liu B, Liu Y, Yang B, Li Y, Zhang X, Hou J, Chen L. Three urban areas of China: a cohort study of maternal-infant factors and HM protein components. Food Funct. 2022 May 10;13(9):5202-5214. doi: 10.1039/d1fo04123a.
citation: Zhao J, Yi W, Liu B, Dai Y, Jiang T, Chen S, Wang J, Feng B, Qiao W, Liu Y, Zhou H, He J, Hou J, Chen L. MFGM components promote gut Bifidobacterium growth in infant and in vitro. Eur J Nutr. 2022 Feb;61(1):277-288. doi: 10.1007/s00394-021-02638-5. Epub 2021 Jul 29.