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

Avva Rus, JSC150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Viral Gastroenteritis

Interventions

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 4 Years

Medical Language ↔ Plain English

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.

Locations (2)

Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov

Arhangelsk, Arhangelskaya Oblast, Russia

RECRUITING

St. Vladimir Children's Moscow Clinical Hospital

Moscow, Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

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).