Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children

June 18, 2026 updated by: Mamoona Feroz, Children Hospital and Institute of Child Health, Lahore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Children Hospital and Institute of Child Health, Lahore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bacillus clausii Group
Participants will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.
Drug: Enterogermina
Bacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.
Active Comparator: Multistrain Probiotic Group
Participants will receive a multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.
Drug: Ecotec
Multistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Diarrhea
Time Frame: 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.
Up to 5 days after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Stool Frequency
Time Frame: Daily for 5 days after initiation of treatment
Number of stools passed per day during the treatment period.
Daily for 5 days after initiation of treatment
Stool Consistency
Time Frame: Daily for 5 days after initiation of treatment
Change in stool consistency assessed daily during the treatment period.
Daily for 5 days after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children Hospital and Institute of Child Health, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCHS-MDPEDS-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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