Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Yung-Feng Huang, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01480947
First received: November 24, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Diarrhea
Drug: Bio-three
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment Effect of Bio-Three on Children With Enteritis Due to Salmonella or Rotavirus or Any Unknown Reason

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Quantitative Vesikari scales and qualitative severe diarrhea [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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


Enrollment: 80
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   3 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480947

Locations
Taiwan
Department of Pediatrics, Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
National Yang Ming University
Investigators
Principal Investigator: Yung-Feng Huang, MD. MSc Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
  More Information

No publications provided

Responsible Party: Yung-Feng Huang, Consultant Physician, Department of Pediatrics, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01480947     History of Changes
Other Study ID Numbers: VGHKS98-CT1-11
Study First Received: November 24, 2011
Last Updated: November 28, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
probiotics
pediatric
salmonella
rotavirus
gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 19, 2014