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:

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 Intervention Model: Parallel Assignment Masking: Double Blind (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:

MedlinePlus related topics: Diarrhea Health Facilities

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 ]

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


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

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


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

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 July 19, 2017

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