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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Phramongkutklao College of Medicine and Hospital.
Recruitment status was  Recruiting
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

January 3, 2011
July 28, 2011
April 2010
August 2011   (final data collection date for primary outcome measure)
monetary cost of hospitalization in Thai Baht [ Time Frame: from admission to discharge date, approximately 1-7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01273012 on ClinicalTrials.gov Archive Site
days of hospitalization [ Time Frame: from admission to discharge date, approximately 1-7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Acute Diarrhea
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
December 2011
August 2011   (final data collection date for primary outcome measure)

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)
Both
3 Months to 6 Years
No
Thailand
 
NCT01273012
P001h/53
No
LTC Nopaorn Phavichitr, Department of Pediatrics, Phramongkutklao Hospital
Phramongkutklao College of Medicine and Hospital
Not Provided
Principal Investigator: Nopaorn Phavichitr, MD Department of Pediatrics, Phramongkutklao
Phramongkutklao College of Medicine and Hospital
July 2011

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