About this trial
This randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Participants will receive one of the probiotic treatments along with standard therapy including oral rehydration solution and zinc supplementation. The study will evaluate the duration of diarrhea, stool frequency, and stool consistency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with Acute watery diarrhea aged 1 year to 5 years.
Both genders will be included.
Patients whose guardians/ parents will give informed consent will participate in the study.
Patients having mild to moderate dehydration will be included in study.
Disqualifiers
Children having history of chronic diarrhea.
Children having history of blood in stools.
Children having cholera.
Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc).
Trial design
Parallel
Treatments tested in this trial
Enterogermina
DrugBacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.
Ecotec
DrugMultistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.
Treatment groups
Trial outcomes
Primary outcomes
Duration of Diarrhea
The duration of acute diarrhea is determined by the timeframe (measured in days) spanning from the initial occurrence of abnormal (loose or liquid) stools to the subsequent return of normal stool consistency. This assessment will consider both the frequency of daily stools and their consistency.
Secondary outcomes
Daily Stool Frequency
Number of stools passed per day during the treatment period.
Stool Consistency
Change in stool consistency assessed daily during the treatment period.
Sponsors and contacts
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