The Treatment Effect of Bio-Three on Children With Enteritis

NCT01480947 | Completed Phase 4 DMC

• 1 other identifier: VGHKS98-CT1-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteritis; Diarrhea

Keywords

probiotics; pediatric; salmonella; rotavirus; gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Study Arms (2)

Bio-Three

EXPERIMENTAL

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

Drug: Bio-three

control treatment

NO INTERVENTION

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

Drug: Bio-three

Interventions

Bio-three 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.

Bio-Three; control treatment

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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
• immunodeficiency
• probiotics use in the preceding 1 week

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Department of Pediatrics, Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Gastroenteritis; Diarrhea

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yung-Feng Huang, MD. MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician, Department of Pediatrics

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

TW (1)