Viral Gastroenteritis
Conditions
Keywords
enterosorbent, sorbent, gastrointestinal decontamination, viral diarrhea, rotavirus, Filtrum, Filtrum-STI, lignin
Brief summary
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
Interventions
DRUGFiltrum-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.
DRUGPlacebo
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.
Sponsors
St. Vladimir Moscow Children's Clinical Hospital
Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
Avva Rus, JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 4 Years
Healthy volunteers
No
Inclusion criteria
* children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis; * 72 h or less from the onset of gastrointestinal symptoms.
Exclusion criteria
* severe diseases; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of gastroenteritis | Day 7 after start of the intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secretory IgA | Day 7 after start of the intervention | — |
| Severity of gastroenteritis | Day 10-14 after end of the intervention | 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). |
| Scatological examination | Day 7 after start of the intervention | — |
| Dysbacteriosis analysis | Day 7 after start of the intervention | — |
| Intestinal Viruses detection and quantification | Day 7 after start of the intervention | It is measured by PCR laboratory test |
| Blood test | Day 7 after start of the intervention | — |
| Biochemical blood analysis | Day 7 after start of the intervention | It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose. |
| Urine analysis | Day 7 after start of the intervention | — |
| Vital functions | Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one | It includes Heart rate, Breathing rate, Body temperature. |
Countries
Russia
Contacts
Primary ContactLyudmila Kobeleva, MD, PhD
Backup ContactNickolay Kryuchkov, MD, PhD, MPH
Outcome results
None listed