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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06540209
Enrollment
60
Registered
2024-08-06
Start date
2023-04-01
Completion date
2023-09-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Watery Diarrhea

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.

Interventions

Children will be give Bacillus clausii for 5 days

Children will be give Saccharomyces boulardii for 5 days

DRUGZinc

Zinc will be given to all children for 5 days

DRUGORS

ORS will be given to all children for 5 days

Sponsors

RESnTEC, Institute of Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stool frequency5 daysNumber of stools per day
Stool consistency5 daysGraded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026