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

Omnifarma

Status and phase: Completed; Phase 2

Conditions: Diarrhoea;Acute

Treatments: Drug: Carbowhite; Drug: Carbowhite placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03633344

CRID CODE-7-180

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 2 patient groups, including a placebo group

Carbowhite

Active Comparator group

Description:

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Treatment:

Drug: Carbowhite

Carbowhite placebo

Placebo Comparator group

Description:

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Treatment:

Drug: Carbowhite placebo