A Cohort Analysis Study of Intestinal Flora in Infants

NCT03396198 | Unknown

• 1 other identifier: MJiang
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the influence factors of gastrointestinal microbiome in infants.

Conditions

Gastrointestinal Microbiome

Keywords

Gastrointestinal Microbiome; Infants

Outcome Measures

Primary Outcomes (1)

• Intestinal Flora Sequencing

  Intestinal Flora Sequencing

  Intestinal Flora Sequencing Change from Baseline to 12 months after Birth

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Residents of the city of Hangzhou

You may qualify if:

• Healthy newborns

You may not qualify if:

• Newborns with diseases such as congenital heart disease or congenital malformation and so on

Sponsors & Collaborators

• Mizu Jiang: lead

Study Sites (1)

The Gastroenterology Laboratory

Hangzhou, Zhejiang, 310051, China

RECRUITING

Related Publications (11)

• Martin R, Makino H, Cetinyurek Yavuz A, Ben-Amor K, Roelofs M, Ishikawa E, Kubota H, Swinkels S, Sakai T, Oishi K, Kushiro A, Knol J. Early-Life Events, Including Mode of Delivery and Type of Feeding, Siblings and Gender, Shape the Developing Gut Microbiota. PLoS One. 2016 Jun 30;11(6):e0158498. doi: 10.1371/journal.pone.0158498. eCollection 2016.

  PMID: 27362264 BACKGROUND

• Arrieta MC, Stiemsma LT, Amenyogbe N, Brown EM, Finlay B. The intestinal microbiome in early life: health and disease. Front Immunol. 2014 Sep 5;5:427. doi: 10.3389/fimmu.2014.00427. eCollection 2014.

  PMID: 25250028 BACKGROUND

• Wopereis H, Oozeer R, Knipping K, Belzer C, Knol J. The first thousand days - intestinal microbiology of early life: establishing a symbiosis. Pediatr Allergy Immunol. 2014 Aug;25(5):428-38. doi: 10.1111/pai.12232. Epub 2014 Jun 5.

  PMID: 24899389 BACKGROUND

• Azad MB, Konya T, Maughan H, Guttman DS, Field CJ, Chari RS, Sears MR, Becker AB, Scott JA, Kozyrskyj AL; CHILD Study Investigators. Gut microbiota of healthy Canadian infants: profiles by mode of delivery and infant diet at 4 months. CMAJ. 2013 Mar 19;185(5):385-94. doi: 10.1503/cmaj.121189. Epub 2013 Feb 11.

  PMID: 23401405 BACKGROUND

• Penders J, Gerhold K, Stobberingh EE, Thijs C, Zimmermann K, Lau S, Hamelmann E. Establishment of the intestinal microbiota and its role for atopic dermatitis in early childhood. J Allergy Clin Immunol. 2013 Sep;132(3):601-607.e8. doi: 10.1016/j.jaci.2013.05.043. Epub 2013 Jul 27.

  PMID: 23900058 BACKGROUND

• Penders J, Gerhold K, Thijs C, Zimmermann K, Wahn U, Lau S, Hamelmann E. New insights into the hygiene hypothesis in allergic diseases: mediation of sibling and birth mode effects by the gut microbiota. Gut Microbes. 2014 Mar-Apr;5(2):239-44. doi: 10.4161/gmic.27905. Epub 2014 Jan 23.

  PMID: 24637604 BACKGROUND

• Backhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. No abstract available.

  PMID: 26308884 BACKGROUND

• Laursen MF, Zachariassen G, Bahl MI, Bergstrom A, Host A, Michaelsen KF, Licht TR. Having older siblings is associated with gut microbiota development during early childhood. BMC Microbiol. 2015 Aug 1;15:154. doi: 10.1186/s12866-015-0477-6.

  PMID: 26231752 BACKGROUND

• Nermes M, Endo A, Aarnio J, Salminen S, Isolauri E. Furry pets modulate gut microbiota composition in infants at risk for allergic disease. J Allergy Clin Immunol. 2015 Dec;136(6):1688-1690.e1. doi: 10.1016/j.jaci.2015.07.029. Epub 2015 Sep 3. No abstract available.

  PMID: 26343452 BACKGROUND

• Hooper LV, Gordon JI. Commensal host-bacterial relationships in the gut. Science. 2001 May 11;292(5519):1115-8. doi: 10.1126/science.1058709.

  PMID: 11352068 BACKGROUND

• Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.

  PMID: 23985870 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Feces and human breast milk

Study Officials

• Mizu Jiang, Doctor

  The Affiliated Children's Hospital of Zhejiang University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mizu Jiang, Doctor

CONTACT

+8613857107171; mizu@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastroenterology Laboratory of the Affiliated Children's Hospital of Zhejiang University Medical School

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 10, 2018
• Study Start: December 22, 2017
• Primary Completion: June 22, 2020
• Study Completion: December 22, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after Publication
• Access Criteria: All the Researchers who Studied the Influence Factors of Intestinal Flora

Locations

CN (1)