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

Viral Gastroenteritis Clinical Trial

— F-GE-09  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01113346
• Other study ID #: 03/09-AVVA RUS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 12, 2010
• Last updated: July 13, 2010
• Start date: June 2010
• Est. completion date: February 2011

Study information

• Verified date: July 2010
• Source: Avva Rus, JSC
• Contact: Lyudmila Kobeleva, MD, PhD
• Phone: +7-495-9567559
• Email: kobeleva[@]avva-rus.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Federal Service on surveillance in Healthcare and Social development (Roszdravnadzor)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 4 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenovirus Infections, Human
• Enteritis
• Enterovirus Infections
• Gastroenteritis
• Viral Gastroenteritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov	Arhangelsk	Arhangelskaya oblast
Russian Federation	St. Vladimir Children's Moscow Clinical Hospital	Moscow

Sponsors (3)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 7 after start of the intervention	No
Secondary	Intestinal Viruses detection and quantification	It is measured by PCR laboratory test	Day 7 after start of the intervention	No
Secondary	Secretory IgA		Day 7 after start of the intervention	No
Secondary	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).	Day 10-14 after end of the intervention	No
Secondary	Scatological examination		Day 7 after start of the intervention	No
Secondary	Scatological examination		Day 10-14 after end of the intervention	No
Secondary	Dysbacteriosis analysis		Day 7 after start of the intervention	No
Secondary	Intestinal Viruses detection and quantification		Day 10-14 after end of the intervention	No
Secondary	Secretory IgA		Day 10-14 after end of the intervention	No
Secondary	Vital functions	It includes Heart rate, Breathing rate, Body temperature.	Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one	Yes
Secondary	Blood test		Day 7 after start of the intervention	Yes
Secondary	Biochemical blood analysis	It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.	Day 7 after start of the intervention	Yes
Secondary	Urine analysis		Day 7 after start of the intervention	Yes