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

• Status: Unknown status
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avva Rus, JSC
• Collaborators: Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.; St. Vladimir Moscow Children's Clinical Hospital

Criteria

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.