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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.

Conditions
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Diarrhoea;Acute

Intervention / Treatment
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* Drug: Carbowhite
* Drug: Carbowhite placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbowhite<br>3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) | Drug: Carbowhite<br> <br> * Other names: Colloidal Silicon Dioxide;|
| Placebo Comparator: Carbowhite placebo<br>3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) | Drug: Carbowhite placebo<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Frequency of Defecation to 3 Times Per Day | 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 | From randomisation up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance Rate | Percent of patients administered the investigational production who discontinued the study | From randomisation up to 5 days | 
| Duration of Treatment | Mean duration of treatment | From randomisation up to 5 days | 
| Quantity of Used Medication | Mean quantity of tablets per treatment course | From randomisation up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhoea, Carbowhite, Colloidal silicon dioxide