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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

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Detailed Description

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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.

Conditions

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Acute Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

The group of patients treated with placebo.

Group Type PLACEBO_COMPARATOR

Probiotic - Infloran

Intervention Type DRUG

Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid

Infloran

The group of patients treated with Infloran.

Group Type EXPERIMENTAL

Probiotic - Infloran

Intervention Type DRUG

Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Infloran L. acidophilus B. bifidum

Eligibility Criteria

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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)

Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No