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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Avva Rus, JSC.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
St. Vladimir Moscow Children's Clinical Hospital
Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
Information provided by:
Avva Rus, JSC
ClinicalTrials.gov Identifier:
NCT01113346
First received: April 12, 2010
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Viral Gastroenteritis
Drug: Filtrum-STI (lignin hydrolytic)
Drug: Placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Avva Rus, JSC:

Primary Outcome Measures:
  • Severity of gastroenteritis [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: No ]
    It is measured by PCR laboratory test

  • Secretory IgA [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: No ]
  • Severity of gastroenteritis [ Time Frame: Day 10-14 after end of the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: No ]
  • Scatological examination [ Time Frame: Day 10-14 after end of the intervention ] [ Designated as safety issue: No ]
  • Dysbacteriosis analysis [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: No ]
  • Intestinal Viruses detection and quantification [ Time Frame: Day 10-14 after end of the intervention ] [ Designated as safety issue: No ]
  • Secretory IgA [ Time Frame: Day 10-14 after end of the intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    It includes Heart rate, Breathing rate, Body temperature.

  • Blood test [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: Yes ]
  • Biochemical blood analysis [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: Yes ]
    It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.

  • Urine analysis [ Time Frame: Day 7 after start of the intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: lignin hydrolytic, sorbent, enterosorbent
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.


  Eligibility

Ages Eligible for Study:   1 Month to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113346

Contacts
Contact: Lyudmila Kobeleva, MD, PhD +7-495-9567559 kobeleva@avva-rus.ru
Contact: Nickolay Kryuchkov, MD, PhD, MPH +7-495-9567559 nkryuchkov@avva-rus.ru

Locations
Russian Federation
Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov Recruiting
Arhangelsk, Arhangelskaya oblast, Russian Federation, 163062
Contact: Larisa Titova, MD, PhD    +7-8182-280433    irina-bul@yandex.ru   
Contact: Olga Samodova, MD, DrSc    +7-8182-22-95-42    samodova@atknet.ru   
Principal Investigator: Larisa Titova, MD, PhD         
Sub-Investigator: Olga Samodova, MD, DrSc         
St. Vladimir Children's Moscow Clinical Hospital Recruiting
Moscow, Russian Federation, 107014
Contact: Elena Meskina, MD, DrSc    +7-916-1216172    meskinaelena@mail.ru   
Contact: Lyudmila Feklisova, MD, DrSc    +7-495-2682226    vespamen@yandex.ru   
Sub-Investigator: Lyudmila Feklisova, MD, DrSc         
Principal Investigator: Elena Meskina, MD, DrSc         
Sponsors and Collaborators
Avva Rus, JSC
St. Vladimir Moscow Children's Clinical Hospital
Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
Investigators
Principal Investigator: Elena Meskina, MD, DrSc St. Vladimir Children's Moscow Clinical Hospital
Study Director: Lyudmila Kobeleva, MD, PhD Avva Rus, JSC
Study Director: Nickolay A. Kryuchkov, MD, PhD, MPH Avva Rus, JSC
  More Information

No publications provided

Responsible Party: Dr. Elena Meskina, MD, DrSc, St. Vladimir Moscow Children's Clinical Hospital
ClinicalTrials.gov Identifier: NCT01113346     History of Changes
Other Study ID Numbers: 03/09-AVVA RUS
Study First Received: April 12, 2010
Last Updated: July 13, 2010
Health Authority: Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Federal Service on surveillance in Healthcare and Social development (Roszdravnadzor)

Keywords provided by Avva Rus, JSC:
enterosorbent
sorbent
gastrointestinal decontamination
viral diarrhea
rotavirus
Filtrum
Filtrum-STI
lignin

Additional relevant MeSH terms:
Gastroenteritis
Enteritis
Adenovirus Infections, Human
Enterovirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adenoviridae Infections
DNA Virus Infections
Virus Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 23, 2014