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

Not Applicable

Completed

• Conditions: Acute Watery Diarrhea
• Interventions: Drug: Bacillus clausii; Drug: Saccharomyces boulardii; Drug: Zinc; Drug: ORS

• Registration Number: NCT06540209
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

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.

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 Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacillus clausii + zinc+ ORS group	Bacillus clausii	Patients received zinc supplementation with ORS and Bacillus clausii
Saccharomyces boulardii +zinc+ ORS group	Saccharomyces boulardii	Patients were given zinc with ORS and Saccharomyces boulardii
Saccharomyces boulardii +zinc+ ORS group	ORS	Patients were given zinc with ORS and Saccharomyces boulardii
Bacillus clausii + zinc+ ORS group	Zinc	Patients received zinc supplementation with ORS and Bacillus clausii
Bacillus clausii + zinc+ ORS group	ORS	Patients received zinc supplementation with ORS and Bacillus clausii
Saccharomyces boulardii +zinc+ ORS group	Zinc	Patients were given zinc with ORS and Saccharomyces boulardii

Primary Outcome Measures

Name	Time	Method
Stool frequency	5 days	Number of stools per day
Stool consistency	5 days	Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery

Trial Locations

Locations (1)

University of Child Health Sciences, The Children's Hospital; 🇵🇰 Lahore, Punjab, Pakistan