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Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children

Sponsor: Children Hospital and Institute of Child Health, Lahore • ClinicalTrials.gov ID: NCT07660367

Registry updated: 2026-10-13

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Description

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.

Interventions

Enterogermina (Drug)
Bacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.
Ecotec (Drug)
Multistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.

Eligibility criteria

Inclusion Criteria: 1. Patient with Acute watery diarrhea aged 1 year to 5 years. 2. Both genders will be included. 3. Patients whose guardians/ parents will give informed consent will participate in the study. 4. Patients having mild to moderate dehydration will be included in study. 5. Patients having mild to moderate malnutrition will be included in study. Exclusion Criteria: 1. Children having history of chronic diarrhea. 2. Children having history of blood in stools. 3. Children having cholera. 4. Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc). 5. Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids). 6. Children who have received antibiotics or zinc within the past 72 hours prior to enrollment, as this may interfere with gut flora and probiotic efficacy. 7. Children who have received probiotics as a treatment for the current episode of diarrhea prior to study enrollment. 8. Children with known allergies or hypersensitivity to probiotic components used in the study. 9. Children who needed I/V antibiotics or I/V rehydration after enrollment.

Conditions

Acute Watery Diarrhea

Locations

Children Hospital and Institute of Child Health, Lahore — Lahore, Punjab Province, Pakistan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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