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

Phase 2

• Conditions: Viral Gastroenteritis
• Interventions: Drug: Filtrum-STI (lignin hydrolytic); Drug: Placebo

• Registration Number: NCT01113346
• Lead Sponsor: Avva Rus, JSC

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Study Start: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-13
• Last Update Posted: 2010-07-14
• Primary Completion: 2010-12
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filtrum-STI	Filtrum-STI (lignin hydrolytic)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Severity of gastroenteritis	Day 7 after start of the intervention	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).

Secondary Outcome Measures

Name	Time	Method
Intestinal Viruses detection and quantification	Day 10-14 after end of the intervention
Secretory IgA	Day 10-14 after end of the intervention
Severity of gastroenteritis	Day 10-14 after end of the intervention	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).
Scatological examination	Day 10-14 after end of the intervention
Dysbacteriosis analysis	Day 7 after start of the intervention
Vital functions	Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one	It includes Heart rate, Breathing rate, Body temperature.
Blood test	Day 7 after start of the intervention
Biochemical blood analysis	Day 7 after start of the intervention	It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.
Urine analysis	Day 7 after start of the intervention

Trial Locations

Locations (2)

St. Vladimir Children's Moscow Clinical Hospital; 🇷🇺 Moscow, Russian Federation

Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov; 🇷🇺 Arhangelsk, Arhangelskaya oblast, Russian Federation