A Cohort Analysis Study of Intestinal Flora in Infants | NCT03396198

Studies
A Cohort Analysis Study of Intestinal Flora in Infants

NCT03396198

Sponsor

Mizu Jiang

Status

Unknown status

Last Update Posted

Jul 2, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Gastrointestinal Microbiome

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2017Actual

Primary Completion Date

Jun 22, 2020Estimated

Completion Date

Dec 22, 2020Estimated

First Submitted Date

Dec 22, 2017

First Submission Date that Met QC Criteria

Jan 4, 2018

First Posted Date

Jan 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mizu Jiang, Director of Gastroenterology Laboratory of the Affiliated Children's Hospital of Zhejiang University Medical School, Zhejiang UniversitySponsor-Investigator

Lead Sponsor

Mizu JiangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intestinal Flora Sequencing	Intestinal Flora Sequencing	Intestinal Flora Sequencing Change from Baseline to 12 months after Birth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy newborns

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Residents of the city of Hangzhou

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mizu Jiang, Doctor	Contact	+8613857107171	+8657186770046	mizu@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Mizu Jiang, Doctor	The Affiliated Children's Hospital of Zhejiang University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Gastroenterology Laboratory	Recruiting	Hangzhou	Zhejiang	310051	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27362264	Background	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.
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