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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

R

RESnTEC, Institute of Research

Status

Completed

Conditions

Acute Watery Diarrhea

Treatments

Drug: Saccharomyces boulardii
Drug: Bacillus clausii
Drug: Zinc
Drug: ORS

Study type

Interventional

Funder types

Other

Identifiers

NCT06540209
AWD-CHLAHORE

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

3 months to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Bacillus clausii + zinc+ ORS group
Experimental group
Description:
Patients received zinc supplementation with ORS and Bacillus clausii
Treatment:
Drug: ORS
Drug: Zinc
Drug: Bacillus clausii
Saccharomyces boulardii +zinc+ ORS group
Experimental group
Description:
Patients were given zinc with ORS and Saccharomyces boulardii
Treatment:
Drug: ORS
Drug: Zinc
Drug: Saccharomyces boulardii

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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