Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon
 dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
Background: Diarrhea is a medical condition characterized by frequent stool, more than 3
 times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. The
 fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%.

 Objectives: To demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet
 dosage form (Carbowhite) in patients with acute diarrhea.

 Methods: A randomized clinical trial, double-blind, placebo-controlled, multi-center.
Inclusion Criteria:

 -  signed Informed Consent Form for patient's study participation

 -  male and female patients at the ages from 18 to 55 years

 -  acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or
 less in patients with usually normal stool

 -  body temperature of ≤ 38 °C

 -  patient's ability to adequately cooperate in the process of study

 Exclusion Criteria:

 -  aged of <18 or >55 years;

 -  blood or pus in stool;

 -  body temperature of >38 °C;

 -  episodes of acute diarrhea for the last 30 days;

 -  administration of antidiarrheal products for the last 24 hours;

 -  salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi;
 ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii;
 ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which
 require administration of antimicrobial products;

 -  pregnancy, lactation;

 -  concomitant decompensated diseases or acute conditions which, according to an
 investigator, may affect study results

 -  alcoholism and drug abuse;

 -  participation in any other clinical study.