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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Phramongkutklao College of Medicine and Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273012
First Posted: January 10, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Phramongkutklao College of Medicine and Hospital
January 3, 2011
January 10, 2011
October 12, 2017
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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Unknown status
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)
Sexes Eligible for Study: All
3 Months to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01273012
P001h/53
No
Not Provided
Not Provided
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