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

Primary Purpose

Acute Diarrhea

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Probiotic - Infloran
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Diarrhea focused on measuring probiotic, cost-effectiveness, diarrhea, children, Sum of the monetary cost of the hospitalization

Eligibility Criteria

3 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Pediatrics, Phramongkutklao HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Infloran

Arm Description

The group of patients treated with placebo.

The group of patients treated with Infloran.

Outcomes

Primary Outcome Measures

monetary cost of hospitalization in Thai Baht

Secondary Outcome Measures

days of hospitalization

Full Information

First Posted
January 3, 2011
Last Updated
July 28, 2011
Sponsor
Phramongkutklao College of Medicine and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01273012
Brief Title
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
Acronym
infloran
Official Title
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea
Keywords
probiotic, cost-effectiveness, diarrhea, children, Sum of the monetary cost of the hospitalization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The group of patients treated with placebo.
Arm Title
Infloran
Arm Type
Experimental
Arm Description
The group of patients treated with Infloran.
Intervention Type
Drug
Intervention Name(s)
Probiotic - Infloran
Other Intervention Name(s)
Infloran, L. acidophilus, B. bifidum
Intervention Description
Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid
Primary Outcome Measure Information:
Title
monetary cost of hospitalization in Thai Baht
Time Frame
from admission to discharge date, approximately 1-7 days
Secondary Outcome Measure Information:
Title
days of hospitalization
Time Frame
from admission to discharge date, approximately 1-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nopaorn Phavichitr, MD
Organizational Affiliation
Department of Pediatrics, Phramongkutklao
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nopaorn Phavichitr, MD
Email
nopaorn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ruangvith Tantibhaedhyangkul, MD
Email
ruangvith@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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