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

• 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 ]

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

• 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
• 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
  Intervention: Drug: Filtrum-STI (lignin hydrolytic)
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

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.

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