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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Three | Experimental | add-on treatment of the probiotics (Bio-three) |
|
| control treatment | No Intervention | control treatment (intravenous fluid, oral rice and half strength milk formula) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yung-Feng Huang, MD. MSc | Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |