Viral GastroenteritisPhase 2/3F-GE-09NCT01113346
A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis
A Phase 2/3 study testing Filtrum-STI (lignin hydrolytic) in people with Viral Gastroenteritis, run by Avva Rus, JSC at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Viral Gastroenteritis
- What is being tested?
- Filtrum-STI (lignin hydrolytic)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesRussia
- Study dates
- Jun 2010to Feb 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis;
- 72 h or less from the onset of gastrointestinal symptoms.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Arhangelsk Regional Children's Clinical Hospital named after P.G. Vizshletsov
Arhangelsk, Arhangelskaya Oblast, 163062
Larisa Titova, MD, PhD, +7-8182-280433, irina-bul@yandex.ru
Olga Samodova, MD, DrSc, +7-8182-22-95-42, samodova@atknet.ru
- Recruiting
St. Vladimir Children's Moscow Clinical Hospital
Moscow, Moscow, 107014
Elena Meskina, MD, DrSc, +7-916-1216172, meskinaelena@mail.ru
Lyudmila Feklisova, MD, DrSc, +7-495-2682226, vespamen@yandex.ru
About this study
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
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
- Conditions
- Viral Gastroenteritis
- Being tested
- Filtrum-STI (lignin hydrolytic), Placebo
- Keywords
- enterosorbent, sorbent, gastrointestinal decontamination, viral diarrhea, rotavirus, Filtrum, Filtrum-STI, lignin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtrum-STI (lignin hydrolytic)Drug
Also called lignin hydrolytic, sorbent, enterosorbent
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Filtrum-STI | Experimental | Not described Receives: Drug: Filtrum-STI (lignin hydrolytic) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 7 after start of the intervention
Secondary outcomes (12)
Intestinal Viruses detection and quantification
It is measured by PCR laboratory test
Measured: Day 7 after start of the intervention
Secretory IgA
Measured: Day 7 after start of the intervention
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).
Measured: Day 10-14 after end of the intervention
Scatological examination
Measured: Day 7 after start of the intervention
Scatological examination
Measured: Day 10-14 after end of the intervention
Dysbacteriosis analysis
Measured: Day 7 after start of the intervention
Intestinal Viruses detection and quantification
Measured: Day 10-14 after end of the intervention
Secretory IgA
Measured: Day 10-14 after end of the intervention
Vital functions
It includes Heart rate, Breathing rate, Body temperature.
Measured: Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one
Blood test
Measured: Day 7 after start of the intervention
Biochemical blood analysis
It includes crude protein, alanine aminotransferase, aspartate aminotransferase, bilirubin, blood urea, creatinine, sodium, potassium, glucose.
Measured: Day 7 after start of the intervention
Urine analysis
Measured: Day 7 after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avva Rus, JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Vladimir Moscow Children's Clinical Hospital, Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
- Investigators
- Elena Meskina, MD, DrSc, Principal investigator, St. Vladimir Children's Moscow Clinical HospitalLyudmila Kobeleva, MD, PhD, Study director, Avva Rus, JSCNickolay A. Kryuchkov, MD, PhD, MPH, Study director, Avva Rus, JSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113346
- Sponsor's protocol ID
- 03/09-AVVA RUS
- Acronym
- F-GE-09
- Status last verified
- Jul 2010
- First submitted
- 12 Apr 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01113346
- Acronym / sponsor ID
- F-GE-09 / 03/09-AVVA RUS
- Conditions
- Viral Gastroenteritis
- Keywords
- enterosorbent, sorbent, gastrointestinal decontamination, viral diarrhea, rotavirus, Filtrum, Filtrum-STI, lignin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Avva Rus, JSCIndustry (pharma, biotech, devices)
- Collaborators
- St. Vladimir Moscow Children's Clinical Hospital, Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtrum-STI | Experimental | Drug: Filtrum-STI (lignin hydrolytic) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis;
- 72 h or less from the onset of gastrointestinal symptoms.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filtrum-STI (lignin hydrolytic)Also: lignin hydrolytic, sorbent, enterosorbentFor 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. | Drug | Filtrum-STI |
| PlaceboFor 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. | Drug | Placebo |
Primary outcome
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).
12 secondary outcomes
Intestinal Viruses detection and quantification
Time frame: Day 7 after start of the intervention
Secretory IgA
Time frame: Day 7 after start of the intervention
Severity of gastroenteritis
Time frame: Day 10-14 after end of the intervention
Scatological examination
Time frame: Day 7 after start of the intervention
Scatological examination
Time frame: Day 10-14 after end of the intervention
Dysbacteriosis analysis
Time frame: Day 7 after start of the intervention
Intestinal Viruses detection and quantification
Time frame: Day 10-14 after end of the intervention
Secretory IgA
Time frame: 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
Blood test
Time frame: Day 7 after start of the intervention
Biochemical blood analysis
Time frame: Day 7 after start of the intervention
Urine analysis
Time frame: Day 7 after start of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Meskina, MD, DrSc principal investigator
St. Vladimir Children's Moscow Clinical Hospital
Lyudmila Kobeleva, MD, PhD study director
Avva Rus, JSC
Nickolay A. Kryuchkov, MD, PhD, MPH study director
Avva Rus, JSC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Filtrum-STI (lignin hydrolytic) in people with Viral Gastroenteritis, run by Avva Rus, JSC at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyudmila Kobeleva, MD, PhD (+7-495-9567559, kobeleva@avva-rus.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of gastroenteritis (time frame: Day 7 after start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2010.