Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on February 27, 2015