Clinical Trial: A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Avva Rus, JSC

Current 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intestinal Viruses detection and quantification [ Time Frame: Day 7 after start of the intervention ]
    It is measured by PCR laboratory test
  • Secretory IgA [ Time Frame: Day 7 after start of the intervention ]
  • Severity of gastroenteritis [ Time Frame: Day 10-14 after end 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).
  • 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 ]
    It includes Heart rate, Breathing rate, Body temperature.
  • Blood test [ Time Frame: Day 7 after start of the intervention ]
  • Biochemical blood analysis [ Time Frame: Day 7 after start of the intervention ]
    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 ]


Original Secondary Outcome: Same as current

Information By: Avva Rus, JSC

Dates:
Date Received: April 12, 2010
Date Started: June 2010
Date Completion: February 2011
Last Updated: July 13, 2010
Last Verified: July 2010