Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
Not Applicable
Withdrawn
- Conditions
- Gastroenteritis
- Registration Number
- NCT02080130
- Lead Sponsor
- Sinaloa Pediatric Hospital
- Brief Summary
The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.
- Detailed Description
Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Clinical diagnosis of acute viral gastroenteritis
Exclusion Criteria
- Moderate or severe dehydration
- Malnutrition
- Immunodeficiencies
- Sepsis or bacterial infection
- Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
- Hospitalisation
- No phone number
- Illiteracy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Duration of diarrhoea in hours Up to 7 days
- Secondary Outcome Measures
Name Time Method Percentage of children requiring hospitalisation Up to 7 days Adverse effects Up to 7 days Number of liquid stools Up to seven days
Trial Locations
- Locations (1)
Sinaloa Pediatric Hospital
🇲🇽Culiacan, Sinaloa, Mexico
Sinaloa Pediatric Hospital🇲🇽Culiacan, Sinaloa, Mexico