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Gastrointestinal MicrobiomeNCT03396198

A Cohort Analysis Study of Intestinal Flora in Infants

An observational study of Gastrointestinal Microbiome, run by Mizu Jiang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages Up to 3 yearsHealthy volunteers can take part
Conditions the study is for
Gastrointestinal Microbiome
How many people
100 participants
Where
1 siteChina
Study dates
22 Dec 2017to 22 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Residents of the city of Hangzhou

Who may be able to join

  • Healthy newborns

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mizu Jiang, Doctor contact

+8613857107171 ext. +8657186770046

mizu@zju.edu.cn

China1 site, 1 recruiting

  • The Gastroenterology Laboratory

    Hangzhou, Zhejiang, 310051

    Mizu Jiang, Doctor, +86 13857107171, mizu@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Observational Study of Intestinal Flora in Infants

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

Read the detailed description

The gastrointestinal microbiome is believed to be critically important for infant growth and development. As we all know, the gut microbiota can influence gut maturation, metabolic, immune and brain development in early life. Host genotype, gestational age, antibiotic use, mode of delivery, diet and the context in which the infant is born (rural vs urban, presence of siblings, pets and other factors) can influence the development of infant gut microbiota. In the early life stage, intestinal flora disorders may alter the host immune function and increase the susceptibility to immune or metabolic diseases.

This research intends to establish a birth cohort of healthy newborns. The influence factors of gastrointestinal microbiome will be investigated by means of questionnaire survey, specimen collection and high throughput sequencing analysis. What's more, the correlation of gut microbiome, infant growth as well as related diseases will be explored either. The results will provide constructive suggestions for the establishment of infant normal intestinal flora and play an indispensable role in exploring the occurrence, development and prevention of related diseases.

Keywords
Gastrointestinal Microbiome, Infants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intestinal Flora Sequencing

    Intestinal Flora Sequencing

    Measured: Intestinal Flora Sequencing Change from Baseline to 12 months after Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start22 Dec 2017
  3. Primary completion22 Jun 2020 (estimated)
  4. Study completion22 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03396198
Sponsor's protocol ID
MJiang
Status last verified
Jul 2020
First submitted
22 Dec 2017
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • 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.

    PubMed 27362264

  • 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.

    PubMed 25250028

  • 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.

    PubMed 24899389

  • 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.

    PubMed 23401405

  • 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.

    PubMed 23900058

  • 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.

    PubMed 24637604

  • 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.

    PubMed 26308884

  • 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.

    PubMed 26231752

  • 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.

    PubMed 26343452

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

    PubMed 11352068

  • 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.

    PubMed 23985870

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Microbiome, run by Mizu Jiang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mizu Jiang, Doctor (+8613857107171 ext. +8657186770046, mizu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intestinal Flora Sequencing (time frame: Intestinal Flora Sequencing Change from Baseline to 12 months after Birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03396198, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.

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