Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children

Acute watery diarrhea is a major cause of morbidity among children worldwide, particularly in developing countries. Although oral rehydration solution (ORS) and zinc supplementation remain the cornerstone of treatment, probiotics are increasingly used as adjunctive therapy to reduce the duration and severity of illness.

Bacillus clausii and multistrain probiotic preparations have both demonstrated beneficial effects in children with acute diarrhea. However, evidence comparing their relative effectiveness is limited. This study aims to compare the effectiveness of Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus in the management of acute watery diarrhea in children.

This study is a randomized, open-label, parallel-group controlled trial conducted in the Department of Pediatric Medicine at The Children's Hospital and Institute of Child Health, Lahore. A total of 138 children aged 1-5 years with acute watery diarrhea will be enrolled and randomized in a 1:1 ratio into two treatment groups.

Participants in Group A will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to ORS and zinc supplementation. Participants in Group B will receive the multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to ORS and zinc supplementation.

The primary outcome is duration of diarrhea. Secondary outcomes include stool frequency and stool consistency during the treatment period. The findings of this study may help identify the more effective probiotic strategy for the management of acute watery diarrhea in children and contribute to evidence-based pediatric practice.

• 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.

Primary outcomes

• Duration of Diarrhea [Up to 5 days after initiation of treatment]: 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 [Daily for 5 days after initiation of treatment]: Number of stools passed per day during the treatment period.
• Stool Consistency [Daily for 5 days after initiation of treatment]: Change in stool consistency assessed daily during the treatment period.

Sex: All, ages: 1 Year to 5 Years

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.