Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form 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.