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

This study is currently recruiting participants.

Verified July 2011 by Phramongkutklao College of Medicine and Hospital

Sponsor:

Information provided by:

Phramongkutklao College of Medicine and Hospital

ClinicalTrials.gov Identifier:

NCT01273012

First received: January 3, 2011

Last updated: July 28, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 3, 2011

Last Updated Date

July 28, 2011

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

monetary cost of hospitalization in Thai Baht [ Time Frame: from admission to discharge date, approximately 1-7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01273012 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

days of hospitalization [ Time Frame: from admission to discharge date, approximately 1-7 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research

Condition ^ICMJE

Acute Diarrhea

Intervention ^ICMJE

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

Other Names:

Infloran
L. acidophilus
B. bifidum

Study Arm (s)

Placebo Comparator: Placebo
The group of patients treated with placebo.

Intervention: Drug: Probiotic - Infloran
Experimental: Infloran
The group of patients treated with Infloran.

Intervention: Drug: Probiotic - Infloran

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

128

Estimated Completion Date

December 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

3 Months to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01273012

Other Study ID Numbers ^ICMJE

P001h/53

Has Data Monitoring Committee

Responsible Party

LTC Nopaorn Phavichitr, Department of Pediatrics, Phramongkutklao Hospital

Study Sponsor ^ICMJE

Phramongkutklao College of Medicine and Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nopaorn Phavichitr, MD

Department of Pediatrics, Phramongkutklao

Information Provided By

Phramongkutklao College of Medicine and Hospital

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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