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

NCT02658500 | Unknown DMC

• 1 other identifier: D14110000481400
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Health Behavior

Keywords

early infant feeding; infant intestinal flora; infant health

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Infant Formula

EXPERIMENTAL

200 newborns just consume the infant formula from 0-42 days to six months age.

Dietary Supplement: Infant Formula

Breast Milk

OTHER

100 newborns were just fed with breast milk from after birth to six months age.

Dietary Supplement: breast milk

Interventions

Infant Formula DIETARY_SUPPLEMENT

Also known as: superior quality infant formula

Infant Formula

breast milk DIETARY_SUPPLEMENT

Breast Milk

Eligibility Criteria

• Age: Up to 42 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beijing Sanyuan Foods Co Ltd: lead
• Capital Institute of Pediatrics, China: collaborator
• Peking University: collaborator
• Beijing Ditan Hospital: collaborator

Study Sites (4)

Beijing Ditan Hospital Capital Mendical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Tongzhou Matemal & Child Health Hospital of Beijing

Beijing, Beijing Municipality, 101100, China

RECRUITING

Henan University of Science and Technology

Luoyang, Henan, 471023, China

RECRUITING

Central South University

Changsha, Hunan, 410083, China

RECRUITING

Related Publications (17)

• 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.

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• 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.

  PMID: 20541022 BACKGROUND

• 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.

  PMID: 16002310 BACKGROUND

• 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.

  PMID: 24933584 BACKGROUND

• 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.

  PMID: 21782228 BACKGROUND

• 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.

  PMID: 16978805 BACKGROUND

• 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.

  PMID: 22055271 BACKGROUND

• 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.

  PMID: 22579986 BACKGROUND

• 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.

  PMID: 12788986 BACKGROUND

• 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.

  PMID: 20479681 BACKGROUND

• 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.

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• 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.

  PMID: 26663826 BACKGROUND

• 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.

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• Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

  PMID: 37929831 DERIVED

• 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.

  PMID: 36147300 DERIVED

• 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.

  PMID: 35438093 DERIVED

• 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.

  PMID: 34324046 DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Infant Formula; Milk, Human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages; Milk; Dairy Products

Study Officials

• CHEN LIJUN

  Beijing Sanyuan Foods Co Ltd

  STUDY DIRECTOR

Central Study Contacts

LI JUFANG

CONTACT

86 010-56306349; nmgljf109@163.com

JIANG TIEMIN

CONTACT

86 010-56306597; jiang515910@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)