Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Carbowhite	Carbowhite	3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
Carbowhite placebo	Carbowhite placebo	3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Primary Outcome Measures

Name	Time	Method
Reduction in Frequency of Defecation to 3 Times Per Day	From randomisation up to 5 days	Percent of patients administered the investigational production who achieved the efficacy endpoint (reduction in frequency of defecation to 3 times per day, absence of loose stool) on Day 5 or earlier

Secondary Outcome Measures

Name	Time	Method
Compliance Rate	From randomisation up to 5 days	Percent of patients administered the investigational production who discontinued the study
Duration of Treatment	From randomisation up to 5 days	Mean duration of treatment
Quantity of Used Medication	From randomisation up to 5 days	Mean quantity of tablets per treatment course