Trials / Completed
CompletedNCT03539913
Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 317 (actual)
- Sponsor
- Biocodex · Industry
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Not accepted
Summary
* Primary Objective: o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis. * Secondary Objectives: * To assess the efficacy of the probiotics in improving the frequency and consistency of stools. * To assess the efficacy of the probiotics in avoiding recurrence of diarrhea. * To assess the efficacy of the probiotics on the disease severity. * To assess the safety and tolerability of the studied probiotics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Probiotic : Saccharomyces boulardii | Treatment for 5 days |
| BIOLOGICAL | Probiotic : Bacillus clausii | Treatment for 5 days |
Timeline
- Start date
- 2017-06-19
- Primary completion
- 2018-06-09
- Completion
- 2018-06-09
- First posted
- 2018-05-30
- Last updated
- 2019-01-22
Locations
8 sites across 1 country: Argentina
Source: ClinicalTrials.gov record NCT03539913. Inclusion in this directory is not an endorsement.