Phase 2 N=144 Randomized Double-blind Treatment

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

Diarrhoea;Acute

Bottom Line

View on ClinicalTrials.gov: NCT03633344 ↗

Enrolled (actual)

144

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Reduction in Frequency of Defecation to 3 Times Per Day — 118; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Carbowhite (Drug); Carbowhite placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Omnifarma Kiev LLC
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction in Frequency of Defecation to 3 Times Per Day	118; 24	—
SECONDARY Compliance Rate	0; 0	—
SECONDARY Duration of Treatment	1.7; 2.6	—
SECONDARY Quantity of Used Medication	12; 36	—

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.

Eligibility Criteria

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 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.

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Data sourced from ClinicalTrials.gov (NCT03633344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.