NCT03856138

Brief Summary

Childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. The aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

February 18, 2019

Last Update Submit

February 25, 2019

Conditions

Clinical InfectionMicrobial ColonizationGastroenteritisInflammatory ResponseProbiotics

Outcome Measures

Primary Outcomes (4)

  • Fecal bacteria microbiota

    Bacteria count in feces

    the day of enrollment

  • Fecal bacteria microbiota

    Bacteria count in feces

    3 days after enrollment

  • Fecal bacteria microbiota

    Bacteria count in feces

    7 days after enrollment

  • Fecal bacteria microbiota

    Bacteria count in feces

    1 month after enrollment

Study Arms (3)

diarrhea with probiotics supplement

The children suffered from diarrhea, gastroenteritis oral probiotics during the clinical course

diarrhea without probiotics supplement

The children suffered from diarrhea, gastroenteritis no oral probiotics during the clinical course

healthy control

The children without diarrhea/ gastroenteritis

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with or without diarrhea less than three days, or healthy volunteers. The age of participants is from 6-month-old to 12-year-old.

You may qualify if:

  • Children with or without diarrhea less than three days

You may not qualify if:

  • diabetes
  • chronic liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacteria DNA in feces of human

MeSH Terms

Conditions

Communicable DiseasesGastroenteritis

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Chien-Chang Chen, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 27, 2019

Study Start

December 1, 2015

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

February 27, 2019

Record last verified: 2019-01

Locations

TW(1)