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

Health Behavior Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02658500
• Other study ID #: D14110000481400
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2016
• Last updated: January 14, 2016
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Beijing Sanyuan Foods Co Ltd
• Contact: LI JUFANG
• Phone: 86 010-56306349
• Email: nmgljf109[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 42 Days

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Health Behavior

Intervention

Dietary Supplement:
• Infant Formula

• breast milk

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Mendical University	Beijing	Beijing
China	Tongzhou Matemal & Child Health Hospital of Beijing	Beijing	Beijing
China	Central South University	Changsha	Hunan
China	Henan University of Science and Technology	Luoyang	Henan

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Sanyuan Foods Co Ltd	Beijing Ditan Hospital, Capital Institute of Pediatrics, China, Peking University

Country where clinical trial is conducted

China, 

References & Publications (13)

Ahrné S, Lönnermark E, Wold AE, Aberg N, Hesselmar B, Saalman R, Strannegård IL, Molin G, Adlerberth I. Lactobacilli in the intestinal microbiota of Swedish infants. Microbes Infect. 2005 Aug-Sep;7(11-12):1256-62. Epub 2005 Jun 8. — View 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. — View Citation

Arboleya S, Ang L, Margolles A, Yiyuan L, Dongya Z, Liang X, Solís G, Fernández N, de Los Reyes-Gavilán 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. — View Citation

Bisgaard H, Li N, Bonnelykke K, Chawes BL, Skov T, Paludan-Müller 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. — View 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. — View Citation

Endo A, P?rtty A, Kalliom?ki 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. — View Citation

Fallani M, Young D, Scott J, Norin E, Amarri S, Adam R, Aguilera M, Khanna S, Gil A, Edwards CA, Doré 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. — View 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. Epub 2006 Sep 14. — View 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. Review. — View 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. Review. — View Citation

Rougé C, Goldenberg O, Ferraris L, Berger B, Rochat F, Legrand A, Göbel UB, Vodovar M, Voyer M, Rozé JC, Darmaun D, Piloquet H, Butel MJ, de La Cochetière 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. — View Citation

Schwiertz A, Gruhl B, Löbnitz 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. Epub 2003 Jun 4. — View Citation

Wernimont S, Northington R, Kullen MJ, Yao M, Bettler J. Effect of an a-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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing	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.	up to 8 months	No