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

History of Changes

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:

MedlinePlus related topics: Gastroenteritis

U.S. FDA Resources

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

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 May 23, 2013

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