Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

Acute Diarrhea Clinical Trial

— infloran  

Official title:

Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01273012
• Other study ID #: P001h/53
• 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
• 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)

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

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