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| Name | Class |
|---|---|
| St. Vladimir Moscow Children's Clinical Hospital | UNKNOWN |
| Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G. | UNKNOWN |
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This is a phase II double blind multicenter randomized placebo-controled clinical study aimed to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and improves its natural microflora. The drug is not toxic and well combines with other medication
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filtrum-STI | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filtrum-STI (lignin hydrolytic) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of gastroenteritis | It's measured by ordinal scales (4- and 5-scores) using data about patients' body temperature, bloating, nausea, abdominal pain, meteorism, stool frequency (physical examination and parent-reported questionnaire). | Day 7 after start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Viruses detection and quantification | It is measured by PCR laboratory test | Day 7 after start of the intervention |
| Secretory IgA | Day 7 after start of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyudmila Kobeleva, MD, PhD | Contact | +7-495-9567559 | kobeleva@avva-rus.ru | |
| Nickolay Kryuchkov, MD, PhD, MPH | Contact | +7-495-9567559 | nkryuchkov@avva-rus.ru |
| Name | Affiliation | Role |
|---|---|---|
| Elena Meskina, MD, DrSc | St. Vladimir Children's Moscow Clinical Hospital | Principal Investigator |
| Lyudmila Kobeleva, MD, PhD | Avva Rus, JSC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov | Recruiting | Arhangelsk | Arhangelskaya Oblast | 163062 | Russia |
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| Placebo | Drug | 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. |
|
| Severity of gastroenteritis | It's measured by ordinal scales (4- and 5-scores) using data about patients' body temperature, bloating, nausea, abdominal pain, meteorism, stool frequency (physical examination and parent-reported questionnaire). | Day 10-14 after end of the intervention |
| Scatological examination | Day 7 after start of the intervention |
| Scatological examination | Day 10-14 after end of the intervention |
| Dysbacteriosis analysis | Day 7 after start of the intervention |
| Intestinal Viruses detection and quantification | Day 10-14 after end of the intervention |
| Secretory IgA | Day 10-14 after end of the intervention |
| Vital functions | It includes Heart rate, Breathing rate, Body temperature. | Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one |
| Blood test | Day 7 after start of the intervention |
| Biochemical blood analysis | It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose. | Day 7 after start of the intervention |
| Urine analysis | Day 7 after start of the intervention |
| Nickolay A. Kryuchkov, MD, PhD, MPH |
| Avva Rus, JSC |
| Study Director |
| St. Vladimir Children's Moscow Clinical Hospital | Recruiting | Moscow | Moscow | 107014 | Russia |
|