Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital (infloran)
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ClinicalTrials.gov Identifier: NCT01273012 |
Recruitment Status
: Unknown
Verified July 2011 by Phramongkutklao College of Medicine and Hospital.
Recruitment status was: Recruiting
First Posted
: January 10, 2011
Last Update Posted
: August 1, 2011
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Condition or disease | Intervention/treatment | Phase |
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Acute Diarrhea | Drug: Probiotic - Infloran | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 128 participants |
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 |
Study Start Date : | April 2010 |
Estimated Primary Completion Date : | August 2011 |
Estimated Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
The group of patients treated with placebo.
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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:
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Experimental: Infloran
The group of patients treated with Infloran.
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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:
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- monetary cost of hospitalization in Thai Baht [ Time Frame: from admission to discharge date, approximately 1-7 days ]
- days of hospitalization [ Time Frame: from admission to discharge date, approximately 1-7 days ]

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Ages Eligible for Study: | 3 Months to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Thailand | |
Department of Pediatrics, Phramongkutklao Hospital | Recruiting |
Bangkok, Thailand, 10400 | |
Contact: Nopaorn Phavichitr, MD nopaorn@hotmail.com | |
Contact: Ruangvith Tantibhaedhyangkul, MD ruangvith@gmail.com |
Principal Investigator: | Nopaorn Phavichitr, MD | Department of Pediatrics, Phramongkutklao |
Responsible Party: | LTC Nopaorn Phavichitr, Department of Pediatrics, Phramongkutklao Hospital |
ClinicalTrials.gov Identifier: | NCT01273012 History of Changes |
Other Study ID Numbers: |
P001h/53 |
First Posted: | January 10, 2011 Key Record Dates |
Last Update Posted: | August 1, 2011 |
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 |