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

July 13, 2010 updated by: Avva Rus, JSC

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 107014
        • Recruiting
        • St. Vladimir Children's Moscow Clinical Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lyudmila Feklisova, MD, DrSc
        • Principal Investigator:
          • Elena Meskina, MD, DrSc
    • Arhangelskaya oblast
      • Arhangelsk, Arhangelskaya oblast, Russian Federation, 163062
        • Recruiting
        • Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov
        • Contact:
        • Contact:
        • Principal Investigator:
          • Larisa Titova, MD, PhD
        • Sub-Investigator:
          • Olga Samodova, MD, DrSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Experimental: Filtrum-STI
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.

Other Names:
  • lignin hydrolytic, sorbent, enterosorbent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of gastroenteritis
Time Frame: 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).
Day 7 after start of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal Viruses detection and quantification
Time Frame: Day 7 after start of the intervention
It is measured by PCR laboratory test
Day 7 after start of the intervention
Secretory IgA
Time Frame: Day 7 after start of the intervention
Day 7 after start of the intervention
Severity of gastroenteritis
Time Frame: 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).
Day 10-14 after end of the intervention
Scatological examination
Time Frame: Day 7 after start of the intervention
Day 7 after start of the intervention
Scatological examination
Time Frame: Day 10-14 after end of the intervention
Day 10-14 after end of the intervention
Dysbacteriosis analysis
Time Frame: Day 7 after start of the intervention
Day 7 after start of the intervention
Intestinal Viruses detection and quantification
Time Frame: Day 10-14 after end of the intervention
Day 10-14 after end of the intervention
Secretory IgA
Time Frame: Day 10-14 after end of the intervention
Day 10-14 after end of the intervention
Vital functions
Time Frame: 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.
Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one
Blood test
Time Frame: Day 7 after start of the intervention
Day 7 after start of the intervention
Biochemical blood analysis
Time Frame: Day 7 after start of the intervention
It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.
Day 7 after start of the intervention
Urine analysis
Time Frame: Day 7 after start of the intervention
Day 7 after start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avva Rus, JSC

Collaborators

St. Vladimir Moscow Children's Clinical Hospital
Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.

Investigators

  • Study Director: Nickolay A. Kryuchkov, MD, PhD, MPH, Avva Rus, JSC
  • Principal Investigator: Elena Meskina, MD, DrSc, St. Vladimir Children's Moscow Clinical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (Estimate)

April 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 14, 2010

Last Update Submitted That Met QC Criteria

July 13, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/09-AVVA RUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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