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Not yet recruiting NCT07660367

Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children

No phase Interventional Acute Watery Diarrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enterogermina, Ecotec.
Who it may be relevant to
Registry conditions: Acute Watery Diarrhea. Basic parameters: 1 year — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Effectiveness of Bacillus Clausii and Multistrain Probiotics (Lactobacillus Acidophilus, Lactobacillus Bulgaricus, Bifidobacterium, Streptococcus Thermophilus) in the Management of Children With Acute Watery Diarrhea: A Randomised Controlled Trial

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Duration of Diarrhea [Time frame: Up to 5 days after initiation of treatment]
Secondary outcome measures (2)
  • Daily Stool Frequency [Time frame: Daily for 5 days after initiation of treatment]
  • Stool Consistency [Time frame: Daily for 5 days after initiation of treatment]

Eligibility criteria

Inclusion criteria

  • 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.
  • Patients having mild to moderate malnutrition will be included in study.

Exclusion criteria

  • 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).
  • Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids).
  • 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.
  • Children who have received probiotics as a treatment for the current episode of diarrhea prior to study enrollment.
  • Children with known allergies or hypersensitivity to probiotic components used in the study.
  • Children who needed I/V antibiotics or I/V rehydration after enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Children Hospital and Institute of Child Health, Lahore — Lahore

Identifiers

NCT: NCT07660367 · UCHS-MDPEDS-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗