Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients

August 9, 2024 updated by: RESnTEC, Institute of Research
The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.

Study Type

Interventional

Enrollment (Actual)

60

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
        • University of Child Health Sciences, The Children's 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:

  • Patients of either gender
  • Aged 3 months to 5 years
  • With acute watery diarrhea last less fewer than 14 days
  • Presenting with mild to moderate dehydration

Exclusion Criteria:

  • Patients with a history of blood or pus in their stools
  • History of recent antibiotic or probiotic treatment
  • Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
  • Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii

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
Experimental: Bacillus clausii + zinc+ ORS group
Patients received zinc supplementation with ORS and Bacillus clausii
Drug: Bacillus clausii
Children will be give Bacillus clausii for 5 days
Other Names:
  • Probiotics
Drug: Zinc
Zinc will be given to all children for 5 days
Other Names:
  • Standard treatment
Drug: ORS
ORS will be given to all children for 5 days
Other Names:
  • Standard treatment
Experimental: Saccharomyces boulardii +zinc+ ORS group
Patients were given zinc with ORS and Saccharomyces boulardii
Drug: Zinc
Zinc will be given to all children for 5 days
Other Names:
  • Standard treatment
Drug: ORS
ORS will be given to all children for 5 days
Other Names:
  • Standard treatment
Drug: Saccharomyces boulardii
Children will be give Saccharomyces boulardii for 5 days
Other Names:
  • Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: 5 days
Number of stools per day
5 days
Stool consistency
Time Frame: 5 days
Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery
5 days

Collaborators and Investigators

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

Sponsor

RESnTEC, Institute of Research

Investigators

  • Principal Investigator: Wajiha Rizwan, FCPS, University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
  • Principal Investigator: Muhammad Tufail, MBBS, University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
  • Principal Investigator: Azher Abbas Shah, University of Child Health Sciences, The Children's 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)

April 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWD-CHLAHORE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared with other researchers 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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