Clinical trial NCT01113346: A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis
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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Viral Gastroenteritis
Keywords: enterosorbent
sorbent
gastrointestinal decontamination
viral diarrhea
rotavirus
Filtrum
Filtrum-STI
lignin
Lead sponsor: Avva Rus, JSC
Sponsor class: INDUSTRY
Collaborators: name: St. Vladimir Moscow Children's Clinical Hospital
name: Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
First posted: 2010-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Severity of gastroenteritis
timeFrame: Day 7 after start of the intervention
Secondary outcomes:
measure: Intestinal Viruses detection and quantification
timeFrame: Day 7 after start of the intervention
measure: Secretory IgA
timeFrame: Day 7 after start of the intervention
measure: Severity of gastroenteritis
timeFrame: Day 10-14 after end of the intervention
measure: Scatological examination
timeFrame: Day 7 after start of the intervention
measure: Scatological examination
timeFrame: Day 10-14 after end of the intervention
measure: Dysbacteriosis analysis
timeFrame: Day 7 after start of the intervention
measure: Intestinal Viruses detection and quantification
timeFrame: Day 10-14 after end of the intervention
measure: Secretory IgA
timeFrame: Day 10-14 after end of the intervention
measure: Vital functions
timeFrame: Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one
measure: Blood test
timeFrame: Day 7 after start of the intervention
measure: Biochemical blood analysis
timeFrame: Day 7 after start of the intervention
measure: Urine analysis
timeFrame: Day 7 after start of the intervention
Other outcomes:
Locations:
city: Arhangelsk
country: Russian Federation
facility: Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov
state: Arhangelskaya oblast
city: Moscow
country: Russian Federation
facility: St. Vladimir Children's Moscow Clinical Hospital
Study officials:
affiliation: St. Vladimir Children's Moscow Clinical Hospital
name: Elena Meskina, MD, DrSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Avva Rus, JSC
name: Lyudmila Kobeleva, MD, PhD
role: STUDY_DIRECTOR
affiliation: Avva Rus, JSC
name: Nickolay A. Kryuchkov, MD, PhD, MPH
role: STUDY_DIRECTOR
References: