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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
  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
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

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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

Responsible Party: LTC Nopaorn Phavichitr, Department of Pediatrics, Phramongkutklao Hospital
ClinicalTrials.gov Identifier: NCT01273012     History of Changes
Other Study ID Numbers: P001h/53
First Submitted: January 3, 2011
First Posted: January 10, 2011
Last Update Posted: October 12, 2017
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