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OpenTrials
Completed

NCT Number: NCT06540209

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

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.

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Key information

Conditions

Acute Watery Diarrhea

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Child Health Sciences, The Children's Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bacillus clausii

Drug

Children will be give Bacillus clausii for 5 days

Other names: Probiotics

Saccharomyces boulardii

Drug

Children will be give Saccharomyces boulardii for 5 days

Other names: Probiotics

Zinc

Drug

Zinc will be given to all children for 5 days

Other names: Standard treatment

ORS

Drug

ORS will be given to all children for 5 days

Other names: Standard treatment

Primary outcomes

  1. Stool frequency

    Time frame: 5 days

    Number of stools per day

  2. Stool consistency

    Time frame: 5 days

    Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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