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

K

Kaohsiung Veterans General Hospital

Status and phase

Completed
Phase 4

Conditions

Diarrhea
Gastroenteritis

Treatments

Drug: Bio-three

Study type

Interventional

Funder types

Other

Identifiers

NCT01480947
VGHKS98-CT1-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

3 months to 14 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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