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

Primary Purpose

Viral Gastroenteritis

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Filtrum-STI (lignin hydrolytic)
Placebo
Sponsored by
Avva Rus, JSC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Gastroenteritis focused on measuring enterosorbent, sorbent, gastrointestinal decontamination, viral diarrhea, rotavirus, Filtrum, Filtrum-STI, lignin

Eligibility Criteria

1 Month - 4 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Arhangelsk Regional Children's Clinical Hospital named after P.G. VizshletsovRecruiting
  • St. Vladimir Children's Moscow Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Filtrum-STI

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Intestinal Viruses detection and quantification
It is measured by PCR laboratory test
Secretory IgA
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).
Scatological examination
Scatological examination
Dysbacteriosis analysis
Intestinal Viruses detection and quantification
Secretory IgA
Vital functions
It includes Heart rate, Breathing rate, Body temperature.
Blood test
Biochemical blood analysis
It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.
Urine analysis

Full Information

First Posted
April 12, 2010
Last Updated
July 13, 2010
Sponsor
Avva Rus, JSC
Collaborators
St. Vladimir Moscow Children's Clinical Hospital, Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
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1. Study Identification

Unique Protocol Identification Number
NCT01113346
Brief Title
A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Avva Rus, JSC
Collaborators
St. Vladimir Moscow Children's Clinical Hospital, Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Gastroenteritis
Keywords
enterosorbent, sorbent, gastrointestinal decontamination, viral diarrhea, rotavirus, Filtrum, Filtrum-STI, lignin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Filtrum-STI
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Filtrum-STI (lignin hydrolytic)
Other Intervention Name(s)
lignin hydrolytic, sorbent, enterosorbent
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of gastroenteritis
Description
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).
Time Frame
Day 7 after start of the intervention
Secondary Outcome Measure Information:
Title
Intestinal Viruses detection and quantification
Description
It is measured by PCR laboratory test
Time Frame
Day 7 after start of the intervention
Title
Secretory IgA
Time Frame
Day 7 after start of the intervention
Title
Severity of gastroenteritis
Description
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).
Time Frame
Day 10-14 after end of the intervention
Title
Scatological examination
Time Frame
Day 7 after start of the intervention
Title
Scatological examination
Time Frame
Day 10-14 after end of the intervention
Title
Dysbacteriosis analysis
Time Frame
Day 7 after start of the intervention
Title
Intestinal Viruses detection and quantification
Time Frame
Day 10-14 after end of the intervention
Title
Secretory IgA
Time Frame
Day 10-14 after end of the intervention
Title
Vital functions
Description
It includes Heart rate, Breathing rate, Body temperature.
Time Frame
Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one
Title
Blood test
Time Frame
Day 7 after start of the intervention
Title
Biochemical blood analysis
Description
It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.
Time Frame
Day 7 after start of the intervention
Title
Urine analysis
Time Frame
Day 7 after start of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lyudmila Kobeleva, MD, PhD
Phone
+7-495-9567559
Email
kobeleva@avva-rus.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Nickolay Kryuchkov, MD, PhD, MPH
Phone
+7-495-9567559
Email
nkryuchkov@avva-rus.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Meskina, MD, DrSc
Organizational Affiliation
St. Vladimir Children's Moscow Clinical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyudmila Kobeleva, MD, PhD
Organizational Affiliation
Avva Rus, JSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nickolay A. Kryuchkov, MD, PhD, MPH
Organizational Affiliation
Avva Rus, JSC
Official's Role
Study Director
Facility Information:
Facility Name
Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov
City
Arhangelsk
State/Province
Arhangelskaya oblast
ZIP/Postal Code
163062
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larisa Titova, MD, PhD
Phone
+7-8182-280433
Email
irina-bul@yandex.ru
First Name & Middle Initial & Last Name & Degree
Olga Samodova, MD, DrSc
Phone
+7-8182-22-95-42
Email
samodova@atknet.ru
First Name & Middle Initial & Last Name & Degree
Larisa Titova, MD, PhD
First Name & Middle Initial & Last Name & Degree
Olga Samodova, MD, DrSc
Facility Name
St. Vladimir Children's Moscow Clinical Hospital
City
Moscow
ZIP/Postal Code
107014
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Meskina, MD, DrSc
Phone
+7-916-1216172
Email
meskinaelena@mail.ru
First Name & Middle Initial & Last Name & Degree
Lyudmila Feklisova, MD, DrSc
Phone
+7-495-2682226
Email
vespamen@yandex.ru
First Name & Middle Initial & Last Name & Degree
Lyudmila Feklisova, MD, DrSc
First Name & Middle Initial & Last Name & Degree
Elena Meskina, MD, DrSc

12. IPD Sharing Statement

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

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