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The Treatment Effect of Bio-Three on Children With Enteritis

NCT ID: NCT01480947

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Gastroenteritis Diarrhea

Keywords

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probiotics pediatric salmonella rotavirus gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bio-Three

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

Group Type EXPERIMENTAL

Bio-three

Intervention Type DRUG

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.

control treatment

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

Group Type NO_INTERVENTION

Bio-three

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Yung-Feng Huang

Consultant Physician, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yung-Feng Huang, MD. MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.

Locations

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Department of Pediatrics, Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VGHKS98-CT1-11

Identifier Type: -

Identifier Source: org_study_id