Phase 2
Completed N=144
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Diarrhoea;Acute
Source: ClinicalTrials.gov NCT03633344 ↗
Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Reduction in Frequency of Defecation to 3 Times Per Day — 118; 24 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.