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

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ClinicalTrials.gov Identifier: NCT01273012
Recruitment Status : Unknown
Verified July 2011 by Phramongkutklao College of Medicine and Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : August 1, 2011
Sponsor:
Information provided by:
Phramongkutklao College of Medicine and Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

Condition or disease Intervention/treatment Phase
Acute Diarrhea Drug: Probiotic - Infloran Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
Study Start Date : April 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. monetary cost of hospitalization in Thai Baht [ Time Frame: from admission to discharge date, approximately 1-7 days ]

Secondary Outcome Measures :
  1. days of hospitalization [ Time Frame: from admission to discharge date, approximately 1-7 days ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273012


Locations
Thailand
Department of Pediatrics, Phramongkutklao Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Nopaorn Phavichitr, MD       nopaorn@hotmail.com   
Contact: Ruangvith Tantibhaedhyangkul, MD       ruangvith@gmail.com   
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Investigators
Principal Investigator: Nopaorn Phavichitr, MD Department of Pediatrics, Phramongkutklao
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: LTC Nopaorn Phavichitr, Department of Pediatrics, Phramongkutklao Hospital
ClinicalTrials.gov Identifier: NCT01273012     History of Changes
Other Study ID Numbers: P001h/53
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by Phramongkutklao College of Medicine and Hospital:
probiotic
cost-effectiveness
diarrhea
children
Sum of the monetary cost of the hospitalization

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms