Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Children

March 14, 2025 updated by: Muhammad Aamir Latif

Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Term of Mean Duration of Diarrhea in Children

This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.

Study Type

Interventional

Enrollment (Actual)

184

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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Children Hospital

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:

  • Both genders
  • Aged 6 to 59 months
  • Suffering from acute watery diarrhea for ≤ 7 days

Exclusion Criteria:

  • Children with blood in stool
  • With prior antibiotics use
  • Children under study with duration of stay more than 5 days
  • clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
  • Immunocompromised children
  • Hypersensitivity to probiotics
  • With prior probiotic administration

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Patients received 2 billion spores of probiotic (Bacillus clausii) every 12 hours, contained in a small bottle along with standard treatment as per WHO guidelines.
Drug: Probiotic Bacillus Clausii
Patients were given 2 billion spores of probiotic (Bacillus clausii) every12 hours, contained in a small bottle.
No Intervention: No probiotic group
Patients received only standard treatment as per WHO guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: 5 days
A frequency of defecation of < 3 stools per day marked the effectiveness of the treatment.
5 days
Consistency of stools
Time Frame: 5 days
The treatment was considered effective if the consistency of stools became semi-solid.
5 days

Collaborators and Investigators

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

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Talha Hassan, Children Hospital, Lahore, Pakistan
  • Study Director: Muhammad Zeeshan, Children Hospital, Lahore, Pakistan

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 (Actual)

March 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWD-CH-LAHORE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

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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