NCT00463190

Brief Summary

Probiotic bacteria inhabit the gastrointestinal tracts of healthy individuals and may improve the health status of patients with digestive disease. The first aim of our study will seek to determine if probiotics medication (Bio-Three) inhibit gastrointestinal infection and reduce its inflammatory response in the intestine. The second aim will explore the bacterial count (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in children. We try to seek to gain an advanced understanding of probiotics versus pathogenic microorganism and host interactions, and mucosal immune responses to probiotics in the intestine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

September 19, 2008

Status Verified

April 1, 2007

First QC Date

April 18, 2007

Last Update Submit

September 18, 2008

Conditions

DiarrheaEnteritisEnterocolitis

Keywords

ProbioticsDiarrheaEnterocolitis

Outcome Measures

Primary Outcomes (2)

  • Clinical symptom 2 days after medication

  • Microbiology study 3 days and one week after medication

Interventions

BiothreeDRUG

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical symptom of diarrhea less than 3 days

You may not qualify if:

  • Severe abdominal distension with risk of bowel perforation
  • Risk for sepsis
  • Past history with surgical operation of gastrointestinal tracts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

  • Chen CC, Walker WA. Probiotics and prebiotics: role in clinical disease states. Adv Pediatr. 2005;52:77-113. doi: 10.1016/j.yapd.2005.03.001.

    PMID: 16124337BACKGROUND

  • Chen CC, Kong MS, Lai MW, Chao HC, Chang KW, Chen SY, Huang YC, Chiu CH, Li WC, Lin PY, Chen CJ, Li TY. Probiotics have clinical, microbiologic, and immunologic efficacy in acute infectious diarrhea. Pediatr Infect Dis J. 2010 Feb;29(2):135-8. doi: 10.1097/inf.0b013e3181b530bf.

    PMID: 20135748DERIVED

Related Links

MeSH Terms

Conditions

DiarrheaEnteritisEnterocolitis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Chien-Chang Chen, MD

    Pediatrics, Chang Gung Memorial Hospital & Chang Gung University College of Medicine & Chang Gung Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

February 1, 2006

Study Completion

November 1, 2007

Last Updated

September 19, 2008

Record last verified: 2007-04

Locations

TW(1)