A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis
NCT ID: NCT01113346
Last Updated: 2010-07-14
Study Results
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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UNKNOWN
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2010-06-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Filtrum-STI
Filtrum-STI (lignin hydrolytic)
For children aged less than 1 y.o.: Filtrum-STI, 400mg per day (1/2 tablet 2 times a day) for 7 days.
For children aged 1-4 y.o.: Filtrum-STI, 800mg per day (1 tablet 2 times a day) for 7 days.
Placebo
Placebo
For children aged less than 1 y.o.: Placebo, 1/2 tablet 2 times a day for 7 days.
For children aged 1-4 y.o.: Placebo, 1 tablet 2 times a day for 7 days.
Interventions
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Filtrum-STI (lignin hydrolytic)
For children aged less than 1 y.o.: Filtrum-STI, 400mg per day (1/2 tablet 2 times a day) for 7 days.
For children aged 1-4 y.o.: Filtrum-STI, 800mg per day (1 tablet 2 times a day) for 7 days.
Placebo
For children aged less than 1 y.o.: Placebo, 1/2 tablet 2 times a day for 7 days.
For children aged 1-4 y.o.: Placebo, 1 tablet 2 times a day for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 72 h or less from the onset of gastrointestinal symptoms.
Exclusion Criteria
* individual intolerance of Filtrum-STI
* treatment with antiviral, immunomodulatory drugs during the study and 2 weeks before inclusion
* treatment with pre- pro- and antibiotics 2 weeks before inclusion
* participation in other clinical study 1 month before inclusion and during participation in the study.
1 Month
4 Years
ALL
No
Sponsors
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St. Vladimir Moscow Children's Clinical Hospital
UNKNOWN
Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
UNKNOWN
Avva Rus, JSC
INDUSTRY
Responsible Party
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St. Vladimir Moscow Children's Clinical Hospital
Principal Investigators
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Elena Meskina, MD, DrSc
Role: PRINCIPAL_INVESTIGATOR
St. Vladimir Children's Moscow Clinical Hospital
Lyudmila Kobeleva, MD, PhD
Role: STUDY_DIRECTOR
Avva Rus, JSC
Nickolay A. Kryuchkov, MD, PhD, MPH
Role: STUDY_DIRECTOR
Avva Rus, JSC
Locations
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Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov
Arhangelsk, Arhangelskaya Oblast, Russia
St. Vladimir Children's Moscow Clinical Hospital
Moscow, Moscow, Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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03/09-AVVA RUS
Identifier Type: -
Identifier Source: org_study_id
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