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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01273012
Other study ID # P001h/53
Secondary ID
Status Unknown status
Phase N/A
First received January 3, 2011
Last updated July 28, 2011
Start date April 2010
Est. completion date December 2011

Study information

Verified date July 2011
Source Phramongkutklao College of Medicine and Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.


Description:

Probiotics have been proved to shorten duration of diarrhea in children; whether they are cost-effective is less clear. We'd like to validate the use of Infloran, a proprietary probiotic sold in Thailand, in terms of its cost-effectiveness compared to standard diarrhea care in our hospital setting.


Recruitment information / eligibility

Status Unknown status
Enrollment 128
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 3 Months to 6 Years
Eligibility Inclusion Criteria:

- Children 3 months to 6 years of age

- Hospitalized due to acute diarrhea

Exclusion Criteria:

- History of probiotic treatment in this episode of illness

- History of use of other anti-diarrheal medications

- Chronic gastrointestinal disease(s)

- Severe dehydration

- Severe systemic disease(s)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Probiotic - Infloran
Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid

Locations

Country Name City State
Thailand Department of Pediatrics, Phramongkutklao Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary monetary cost of hospitalization in Thai Baht from admission to discharge date, approximately 1-7 days
Secondary days of hospitalization from admission to discharge date, approximately 1-7 days
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