Colloidal Silicon Dioxide in Tablet form (Carbowhite) Efficacy in Patients with Acute Diarrhea: Results of Randomized, Double- Blind, Placebo-Controlled, Multi- Center Study
Date
2020
Authors
Tieroshyn, Vadym
Moroz, Larisa
Prishliak, Oleksandra
Shostakovich-Koretska, Lyudmila
Kruglova, Oksana
Gordienko, Lyudmila
Journal Title
Journal ISSN
Volume Title
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Abstract
The acute diarrhea is a wide-spread disease. The prescription of enterosorbents is appropriate as
a primary measure for the treatment of the acute diarrhea for effective prevention of the fluid and
electrolyte loss, as well as method for symptom relief of the attack of the disease. Aim of the study - the
antidiarrheal efficacy and safety study of high-dispersion silicon dioxide enterosorbent in tablet dosage
form in patients with acute diarrhea. This was randomized, double-blind, placebo-controlled, 4-center
study. Acute diarrhea was defined as three and more episodes of watery stool per day either during
48 hours or less before study entry in the patients having normal stool recently. It has been postulated
that symptoms and signs of acute diarrhea have to be caused by direct infection of the gastrointestinal
tract and did not associated with moderate-to-severe systemic states. 144 patients with established
acute diarrhea were randomized into treatment group (enterosorbent “Carbowhite”, n = 120) or
placebo group. Date collection including severity diarrhea, systemic symptoms was performed at
baseline and daily during 7 days. Stool examination and serological assay were performed at baseline.
The primary end points were declared as time to complete recovery from acute diarrhea. It has been
found that the use of the siliceous enterosorbent (“Carbowhite”) allowed to reduce (p < 0.001) the
treatment period averagely for 0.9 days (95% confidence interval 0.5–1.2 days) in comparison with
placebo. Data of safety monitoring has revealed that both patient groups had negative stool culture,
while initiation of antibiotic treatment was run more frequently in placebo group (8.3%) compared to
investigational product group (4.1%, P = 0.044). The siliceous enterosorbent “Carbowhite” was well
tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant
form.
Description
Keywords
colloidal silicon dioxide, acute diarrhea, treatment
Citation
Colloidal Silicon Dioxide in Tablet form (Carbowhite) Efficacy in Patients with Acute Diarrhea: Results of Randomized, Double- Blind, Placebo-Controlled, Multi- Center Study / V. Tieroshyn, L. Moroz, O. Prishliak, L. Shostakovich-Koretska, O. Kruglova, L. Gordienko // Scientific Reports. – 2020. – Vol. 10 (6344). – P. 1–11.