A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis

Study Overview
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Brief Summary
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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

Official Title
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Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Filtrum-STI, 0,4g Tablets (Produced by AVVA RUS) in Children With Viral Gastroenteritis

Conditions
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Viral Gastroenteritis

Intervention / Treatment
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* Drug: Filtrum-STI (lignin hydrolytic)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filtrum-STI<br> | Drug: Filtrum-STI (lignin hydrolytic)<br>* 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.<br>* Other names: lignin hydrolytic, sorbent, enterosorbent;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enterosorbent, sorbent, gastrointestinal decontamination, viral diarrhea, rotavirus, Filtrum, Filtrum-STI, lignin