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

July 28, 2011 updated by: Phramongkutklao College of Medicine and Hospital
The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
The group of patients treated with placebo.
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
EXPERIMENTAL: Infloran
The group of patients treated with Infloran.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
monetary cost of hospitalization in Thai Baht
Time Frame: from admission to discharge date, approximately 1-7 days
from admission to discharge date, approximately 1-7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
days of hospitalization
Time Frame: from admission to discharge date, approximately 1-7 days
from admission to discharge date, approximately 1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Investigators

  • Principal Investigator: Nopaorn Phavichitr, MD, Department of Pediatrics, Phramongkutklao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (ESTIMATE)

January 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2011

Last Update Submitted That Met QC Criteria

July 28, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P001h/53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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