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The Treatment Effect of Bio-Three on Children With Enteritis (Bio-three)

Primary Purpose

Gastroenteritis, Diarrhea

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Bio-three
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring probiotics, pediatric, salmonella, rotavirus, gastroenteritis

Eligibility Criteria

3 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical symptom of diarrhea less than 3 days

Exclusion Criteria:

  • Severe abdominal distension with risk of bowel perforation
  • Risk for sepsis
  • Past history with surgical operation of gastrointestinal tracts
  • immunodeficiency
  • probiotics use in the preceding 1 week

Sites / Locations

  • Department of Pediatrics, Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bio-Three

control treatment

Arm Description

add-on treatment of the probiotics (Bio-three)

control treatment (intravenous fluid, oral rice and half strength milk formula)

Outcomes

Primary Outcome Measures

Quantitative Vesikari scales and qualitative severe diarrhea
Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Severity of diarrhea was evaluated according to the following features: volume of stools, fecal consistency, and frequency. Other clinical symptoms or signs, including fever, vomiting, daily intake, dehydration, and treatment were also assessed

Secondary Outcome Measures

Full Information

First Posted
November 24, 2011
Last Updated
November 28, 2011
Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT01480947
Brief Title
The Treatment Effect of Bio-Three on Children With Enteritis
Acronym
Bio-three
Official Title
The Treatment Effect of Bio-Three on Children With Enteritis Due to Salmonella or Rotavirus or Any Unknown Reason
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
National Yang Ming University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Diarrhea due to acute enteritis is a common symptom in the children. Lots of patients are infected by rotavirus or salmonella. Base on the past researches, there is benefit effect of probiotics on patients with diarrhea or acute enteritis. In this clinical study, bio-Three, a probiotic which contains three independent probiotics, will be used in patients with acute diarrhea. This is a single site, controlled clinical research. About 80 patients will be enrolled into this study to evaluate the benefit effect of bio-Three among patients with acute enteritis due to rotavirus or salmonella or other unknown reason. Patients will be diagnosed and screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.
Detailed Description
Intervention: Subjects were randomly assigned to receive control treatment (intravenous fluid, oral rice and half strength milk formula) or add-on treatment of the probiotics (Bio-three®) to the control treatment. Main outcome measures: Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Exclusion criteria included immunodeficiency, severe abdominal distension with risk of bowel perforation, severe infection or sepsis, history of gastrointestinal tract surgery, and probiotics use in the preceding 1 week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis, Diarrhea
Keywords
probiotics, pediatric, salmonella, rotavirus, gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bio-Three
Arm Type
Experimental
Arm Description
add-on treatment of the probiotics (Bio-three)
Arm Title
control treatment
Arm Type
No Intervention
Arm Description
control treatment (intravenous fluid, oral rice and half strength milk formula)
Intervention Type
Drug
Intervention Name(s)
Bio-three
Intervention Description
oral Bio-three three times daily for 7 days, Bio-three dosage plan: 1) patients aged 6 years old, 1 tablet t.i.d.; 2) patients aged between 6 and 12 years old, 2 tablets t.i.d.; 3) patients aged 12 years old, 3 tablets t.i.d.
Primary Outcome Measure Information:
Title
Quantitative Vesikari scales and qualitative severe diarrhea
Description
Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale≥11) Severity of diarrhea was evaluated according to the following features: volume of stools, fecal consistency, and frequency. Other clinical symptoms or signs, including fever, vomiting, daily intake, dehydration, and treatment were also assessed
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical symptom of diarrhea less than 3 days Exclusion Criteria: Severe abdominal distension with risk of bowel perforation Risk for sepsis Past history with surgical operation of gastrointestinal tracts immunodeficiency probiotics use in the preceding 1 week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Feng Huang, MD. MSc
Organizational Affiliation
Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Treatment Effect of Bio-Three on Children With Enteritis

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