A Cohort Analysis Study of Intestinal Flora in Infants

July 1, 2020 updated by: Mizu Jiang

An Observational Study of Intestinal Flora in Infants

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mizu Jiang, Doctor
  • Phone Number: +8657186770046 +8613857107171
  • Email: mizu@zju.edu.cn

Study Locations

  • China
    • Zhe Jiang
      • Hangzhou, Zhe Jiang, China, 310051
        • Recruiting
        • The Gastroenterology Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of the city of Hangzhou

Description

Inclusion Criteria:

  • Healthy newborns

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mizu Jiang

Investigators

  • Principal Investigator: Mizu Jiang, Doctor, The Affiliated Children's Hospital of Zhejiang University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Anticipated)

June 22, 2020

Study Completion (Anticipated)

December 22, 2020

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MJiang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after Publication

IPD Sharing Access Criteria

All the Researchers who Studied the Influence Factors of Intestinal Flora

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Microbiome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe