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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
  Purpose

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


Condition Intervention
Acute Diarrhea
 Drug: Probiotic - Infloran

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Phramongkutklao College of Medicine and Hospital:

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

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

Estimated Enrollment: 128
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 6 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: LTC Nopaorn Phavichitr, Department of Pediatrics, Phramongkutklao Hospital
ClinicalTrials.gov Identifier: NCT01273012     History of Changes
Other Study ID Numbers: P001h/53
Study First Received: January 3, 2011
Last Updated: July 28, 2011
Health Authority: Thailand:Institutional Review Board, Royal Thai Army Medical Department

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

ClinicalTrials.gov processed this record on June 17, 2013