A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis (F-GE-09)

AVVA Pharmaceuticals

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Viral Gastroenteritis

Treatments: Drug: Placebo; Drug: Filtrum-STI (lignin hydrolytic)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01113346

03/09-AVVA RUS

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 1 month to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Filtrum-STI

Experimental group

Treatment:

Drug: Filtrum-STI (lignin hydrolytic)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo