NCT01113346

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Avva Rus, JSC · Industry
• Sex: All
• Age: 1 Month – 4 Years
• Healthy volunteers: Not accepted

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

Conditions

• Viral Gastroenteritis

Interventions

Type	Name	Description
DRUG	Filtrum-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.
DRUG	Placebo	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2010-04-29
• Last updated: 2010-07-14

Locations

2 sites across 1 country: Russia