Acute DiarrheainfloranNCT01273012
Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
A study testing Probiotic - Infloran in people with Acute Diarrhea, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Acute Diarrhea
- What is being tested?
- Probiotic - Infloran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 3 months to 6 years of age
- Hospitalized due to acute diarrhea
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Phramongkutklao Hospital
Bangkok, 10400
Nopaorn Phavichitr, MD, nopaorn@hotmail.com
Ruangvith Tantibhaedhyangkul, MD, ruangvith@gmail.com
About this study
The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.
Read the 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.
- Conditions
- Acute Diarrhea
- Being tested
- Probiotic - Infloran
- Keywords
- probiotic, cost-effectiveness, diarrhea, children, Sum of the monetary cost of the hospitalization
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic - InfloranDrug
Also called Infloran, L. acidophilus, B. bifidum
Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The group of patients treated with placebo. Receives: Drug: Probiotic - Infloran |
| Infloran | Experimental | The group of patients treated with Infloran. Receives: Drug: Probiotic - Infloran |
What is being measured
The primary outcome is the main question the study is designed to answer.
monetary cost of hospitalization in Thai Baht
Measured: from admission to discharge date, approximately 1-7 days
Secondary outcomes (1)
days of hospitalization
Measured: from admission to discharge date, approximately 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startApr 2010
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nopaorn Phavichitr, MD, Principal investigator, Department of Pediatrics, Phramongkutklao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273012
- Sponsor's protocol ID
- P001h/53
- Acronym
- infloran
- Status last verified
- Jul 2011
- First submitted
- 3 Jan 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
- ClinicalTrials.gov ID
- NCT01273012
- Acronym / sponsor ID
- infloran / P001h/53
- Conditions
- Acute Diarrhea
- Keywords
- probiotic, cost-effectiveness, diarrhea, children, Sum of the monetary cost of the hospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Probiotic - InfloranThe group of patients treated with placebo. |
| Infloran | Experimental | Drug: Probiotic - InfloranThe group of patients treated with Infloran. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 3 months to 6 years of age
- Hospitalized due to acute diarrhea
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic - InfloranAlso: Infloran, L. acidophilus, B. bifidumDrug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid | Drug | Infloran, Placebo |
Primary outcome
monetary cost of hospitalization in Thai Baht
Time frame: from admission to discharge date, approximately 1-7 days
1 secondary outcome
days of hospitalization
Time frame: from admission to discharge date, approximately 1-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nopaorn Phavichitr, MD principal investigator
Department of Pediatrics, Phramongkutklao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic - Infloran in people with Acute Diarrhea, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monetary cost of hospitalization in Thai Baht (time frame: from admission to discharge date, approximately 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2011.