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

November 28, 2011 updated by: Yung-Feng Huang, Kaohsiung Veterans General Hospital.

The Treatment Effect of Bio-Three on Children With Enteritis Due to Salmonella or Rotavirus or Any Unknown Reason

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Department of Pediatrics, Kaohsiung Veterans General Hospital

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

3 months to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bio-Three
add-on treatment of the probiotics (Bio-three)
Drug: Bio-three
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.
No Intervention: control treatment
control treatment (intravenous fluid, oral rice and half strength milk formula)
Drug: Bio-three
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Vesikari scales and qualitative severe diarrhea
Time Frame: 7 days
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
7 days

Collaborators and Investigators

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

Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

National Yang Ming University

Investigators

  • Principal Investigator: Yung-Feng Huang, MD. MSc, Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.

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

February 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS98-CT1-11

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.

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